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206591-15_RESTORIS MCK Planning and

1. AP N RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 49 RESTORIS MCK Planning and Surgical Technique Guide Tibial Onlay Technical Data Baseplate Insert Baseplate Peg Peg PegAngle Keel AP AP Insert ML Height Diameter Degrees Height Pi so asl ma To es 80 so oo wo uo re s ss me To es 9 S9 so so vous s s os ms Te es 9 80 so so too zo Size Thickness Pa ao o ro es w 60 se so wo vo s se iss ars se es 39 0 so wo wo io s se s mo se es s 60 se so wo vao r se sis ss se es w 60 se so wo 10 Ls so sof sw se es w 99 eojeo ro0 10 All dimensions in mm unless otherwise noted Insert AP Baseplate Insert ML Baseplate AP Thickness Keel Height Peg Height Peg Diameter 50 RESTORIS MCK Planning and Surgical Technique Guide Patellofemoral Technical Data Size Height Width Peg Height Peg Diameter All dimensions are in mm unless otherwise noted eae eo e Peg Height Height N CZ Width 51 RESTORIS MCK Planning and Surgical Technique Guide Patella Technical Data Peg Circle Diameter om mo eo me s d ow Diameter Thickness Radius Peg Diameter Peg Length m o o o ss s wo All dimensions in mm Thickness Diameter Radius Peg Length Peg Circle Diameter Peg Diameter L 52 RESTORIS MCK
2. Adjust AP SI amp F E to match bone J curve and to be 1 mm proud of bone Adjust F E as necessary to ensure anterior tip is not inset into bone and not protruding through PF transition zone CORONAL 2 0 Internal 2 0 CORONAL oP Internal 207 gt Cein Valgus 69 dh 0 0 Planning and Surgical Technique Guide Options Screen Help Select Proud qmm 17mm All Implants M Display Axes Flexion 0 0 Proud qmm 12mm All Implants SAGITTAL C bd um h e Display Axes mn 1mm proud 1 Flexion In proue RESTORIS MCK Planning and Surgical Technique Guide Pre Operative Femoral Planning Verify Fit Select Medial Femur Verify 1 2 Verify intercomponent gap is 23 mm and the Femoral does not protrude through patellar transition zone 8 Verify intercomponent gap is 23 mm and the Femoral does not protrude through patellar transition zone Anterior tip of Femoral should be slightly proud of bone For a UKA the Femoral should not be proud of the cartilage 70 RESTORIS MCK Planning and Surgical Technique Guide APPENDIX B RESTORIS MCK Implant Planning Intra Operative Sequence e Verify the Pre Operative plan prior to Intra Operative planning he Bicompartmental step in Pre Operative planning is only used to establish initial component sizing therefore is not needed for Intra Operative
3. Obtain pose captures for Mes Case Planning Pre Op F3O Check i Bone Registration intra Op Planning 1 Bone Praper ation f Case Complation Way 7 joint balancing at approximately 45 knee flexion Mid flexion gap balancing Intra Operative Joint Balancing Pose Capture Obtain pose captures for Case Penning Pre Op RIO Check Bone Registration joint balancing at approximately 90 knee flexion Flexion gap balancing ntra Op Planning Bone Preparation Case Completion Options Screen Help Internal Rotation a 73 RESTORIS MCK Planning and Surgical Technique Guide Intra Operative Joint Balancing Pose Capture Obtain pose captures for Case Plannin Pre Op FO Check Bone Registration neon Penning Borse Preparation Case Completion joint balancing at l approximately 100 120 Maximum flexion Joint Balancing 74 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Tibial Component Intra Operative Planning Summary Onlay maximize cortical coverage without overhanging Align edge with tibial eminence ridge 3 mm proud of bone Note mE for the Inlay do not inset Inlay maintain offset of 2 3 more than 3 5 mm below mm from cortical rim cortical bone surface Lateral edge of implant blends with eminence ridge Onlay best match baseplate perimeter with cortical rim Inlay best match inlay perimeter to 2 3 mm cortical rim offset Set implant
4. Chak ia uta Clear fren Setacs Foaour des We Versi Fait rarata Gado Loft Looze 1 9mm Tie distance 1 J mm mpaniPamim Planning and Surgical Technique Guide Intra Operative Femoral Planning Fit Adjust V V to match PF component or to better match Tibial tracking points but stay within positioning limits Adjust F E AP and SI to obtain desired joint balancing gap Goal 0 1 5 mm looseness in graph If mid flexion gap is tight flex Femoral If mid flexion gap is loose extend Femoral If Quick Fit is enabled use Quick Fit at this time Cej Internal t3 Varus ca Options creen Help LU 7 Size 2 x Lateral Femur Primary Poud 1 4 n m pose ri m Flexion 4 5 b pew lecirt r Implant 7 Quick FA Nt we Clee PontGarface Pomt ourface Me Operate Sida loft Loose 1 9mm Tip distance 1 3mm Flexion Implant Planning E ane Intra Operative Femoral Planning Verify Fit Select Medial Femur Verify 1 Verify intercomponent gap is 23 mm and the Femoral does not protrude through patellar transition zone Verify intercomponent gap is 23 mm and the Femoral does not protrude through patellar transition zone Anterior tip of Femoral component should be slightly proud of bone For a UKA the Femoral component should not be proud of the mapped cartilage surface Internal Aa 2 0 P Varus 0 0 Gap 2 3mm ae
5. Primary not overhang 0 2 mm inset Adiust E E ne TN Ao poA Move AP so that from medial and lateral ridges inicie ae O medial tip rests l proximal lateral on in bone surfa tip is split midway by bone component to be 2 mm proud of trochlear groove bone P dll View t o a ta F s Bagad Pn PHIL Primary Most distal point of Set PF wings 2 mm Set Trochlear IE rotation to intercondylar groove Ensure distal tip is 0 4 internal acceptable for proud of bone anterior to implant to be recessed into BI tsli View lateral cortex ee Mie Primary View Verify 2 56 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Femoral Component Pre Operative Planning Summary Set Femoral anterior tip just proud Best match Femoral medial edge of bone and below PF wing to condylar curvature inset from medial edge 1 2 mm Ma aai Best match sagittal J curve Centralize component on condyle offset from bone 1 mm Set implant in Primary view and verify intercomponent gap in Verify 1 57 Planning and Surgical Technique Guide Tibial Component Pre Operative Tibial Planning Default Position Component is imported in Default location Size 5 is Default size Select Medial Tibia Primary Crosshair automatically positioned at implant center 3 5 mm from top Center of medial peg ML midplane E 3D view set to Transverse Proximal Drag and drop c
6. The third party trademarks in this manual are proprietary to their respective owners These companies or their agents have granted MAKO the right to use their trademarks Trademarks registered in the United States Trademark registrations pending in other jurisdictions RIO is a registered trademark of MAKO Surgical Corp MAKOplasty is a registered trademark of MAKO Surgical Corp RESTORIS is a registered trademark of MAKO Surgical Corp Governing Law Any legal action or proceeding related to this manual or the information contained in it shall be brought exclusively in a court in Broward County Florida and shall be governed by the laws of the State of Florida without regard to conflicts of laws principles Software Version 2 5 There are no user serviceable parts in the RIO refer to your MAKO authorized i personnel for service RESTORIS MCK Planning and Surgical Technique Guide DESCRIPTION The RESTORIS MCK MultiCompartmental Knee Implant System consists of two subsystems RESTORIS MCK Unicondylar Uni which has an inlay and onlay option and RESTORIS MCK Patellofemoral PF These two subsystems may be used independently or together in a medial multicompartmental implant system referred to in this manual as the MCK Bicompartmental Inlay or MCK Bicompartmental Onlay See the end of this manual for technical data of all implants Patellofemoral Medial Bicompartmental Inlay or Onlay Patella Dome not pictured Fig
7. under resection of bone and due to introduction of cement after implantation P The trial or implant insert thickness used during Capture Contact must be the same as the Poly thickness selected in the drop down menu If they are not errors in the gap values may result The tibial and femoral arrays should not be moved after resection in order for the j Kinematic Analysis page to work for both trialing and implantation options 81 RESTORIS MCK Planning and Surgical Technique Guide Gap Graph Selecting the graph icon displays the Gap Graph at the top of the page To view the pre resection gap values toggle on Pre Resection The Gap Graph can display gap values for all poses taken during pre resection and post resection for comparison Live Kinematic Values After contact poses are collected live kinematic values are displayed in both sagittal and coronal planes Flexion Angle The live flexion angle of the knee is displayed in the sagittal window When Pre Resection is toggled on the sagittal kinematic window will display blue dots on the flexion dial indicating the flexion angles where pre resection poses were taken When the knee is within 5 flexion of the pre resection pose pre resection values will be displayed in the coronal window Outside the 5 flexion range of pre resection the value boxes will display N A Tibiofemoral Varus Valgus The coronal window displays three values of tibiofemoral varu
8. It is recommended that the leg is passively corrected to be slightly under corrected for the extension pose capture 5 10 flexion Pre Resection Joint Balancing is necessary for enabling full use of the intra operative implant planning features Medical standard of practice is to acquire a minimum of 4 poses full extension full flexion and 2 additional angles in between More than 4 pose captures are possible however it is up to the surgeon s discretion as to how many poses to capture Recommended Pose Captures for Joint Balancing a Listed below are the 4 minimum recommended poses more poses can be captured as needed to ensure a successful implant plan 5 10 Extension gap balancing 45 Mid flexion gap balancing 90 Flexion gap balancing 100 120 Maximum flexion this pose is critical for planning the posterior tibiofemoral articulation during Intra Operative Planning especially for a Lateral Unicondylar procedure Refer to Appendix B for step by step visual instructions 21 RESTORIS MCK Planning and Surgical Technique Guide INTRA OPERATIVE IMPLANT PLANNING During intra operative planning patient specific information gathered in the Joint Balancing step is used to adjust the pre operative implant plan to achieve implant component positions suitable for resection Software functionality for this step can be found in the MAKOplasty Partial Knee Application User Guide PN 206388 15 The gree
9. PF Patellofemoral Trochlear component RESTORIS MCK Tibial Component Pre Operative Planning Summary Onlay maximize cortical coverage without overhanging Align edge with tibial eminence ridge 3 mm proud of bone Note mE for the Inlay do not inset Inlay maintain offset of 2 3 more than 3 5 mm below mm from cortical rim cortical bone surface Lateral edge of implant blends with eminence ridge Onlay best match baseplate perimeter with cortical rim Inlay best match inlay perimeter to 2 3 mm cortical rim offset Set implant in Primary view and scroll through the slices or use the Verify 1 and Verify 2 preset views to verify planning criteria RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 55 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Bicompartmental Pre Operative Planning Summary The Bicompartmental planning step is used to set initial size of the PF trochlear and Femoral Condyle components Changing sizes changes the size of both components Adjusting position simultaneously changes position of both components ee ati Bicompartmental size based on medial AP length Anterior PF is 1 mm proud of bone Posterior Femoral is 2 mm inset or 1 mm proud e feaas annia LETTELE Patellofemoral Trochlear Pre Operative Planning Summary View Primary T Viel 1 View Select largest size that does Mes 2 E d
10. Planning and Surgical Technique Guide APPENDIX A RESTORIS MCK Implant Planning Medial F Appendix A and B describe the sequence of steps required to Pre Operatively and Intra Operatively plan a RESTORIS MCK Bicompartmental RESTORIS MCK Bi Comp These Appendices can also be used to plan the components of a RESTORIS MCK PF and a RESTORIS MCK UKA Although the steps are the same the screen shot pictures will not be representative for a single compartment If only performing an RESTORIS MCK PF or an RESTORIS MCK UKA it is recommended to plan for an RESTORIS MCK Bi Comp to characterize size and fit of each component Foran RESTORIS MCK PF select the RESTORIS MCK PF from the Implant System menu Otherwise Tibia Registration and Joint Balancing will be required Foran RESTORIS MCK UKA exit the RESTORIS MCK Bi Comp and select the RESTORIS MCK UKA from the Implant System menu Otherwise Bicompartmental Registration will be required If this is acceptable remain in RESTORIS MCK Bi Comp and ignore the RESTORIS MCK PF Each transverse coronal and sagittal window in the following recommended technique panel is labeled with a 1 2 or 3 respectively The instructions in the left column are also labeled with a 1 2 or 3 to correspond to the applicable window panel For each component required views in each window panel crosshair are set by choosing the primary or applicable verify option for each component The remainin
11. for use in Australia and New Zealand 26 RESTORIS MCK Planning and Surgical Technique Guide Conversion from RESTORIS MCK Inlay to RESTORIS MCK Onlay 1 Under no circumstances should a conversion from the RESTORIS MCK Implant System to the RESTORIS Implant System be performed The implant geometries are not equivalent Mixing incompatible implant systems could shorten implant life Conversion from the RESTORIS MCK Inlay to the RESTORIS MCK Onlay can occur at any time This conversion is done at the discretion of the operative surgeon To convert follow the steps outlined below 1 Clear RESTORIS MCK Inlay instrumentation and trials from surgical field before bringing in RESTORIS MCK Onlay instrumentation and trials Select the new Tibial component per the MAKOplasty Partial Knee Application User Guide PN 206388 15 Return to Implant Planning and make any adjustments to the plan to ensure proper Tibial Onlay placement Proceed to RESTORIS MCK Onlay resection Bicompartmental or Uni the software application will align the articular surfaces of each tibial component at the same height in the Implant Planning page a When converting from a RESTORIS MCK Inlay to RESTORIS MCK Onlay system RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 2 RESTORIS MCK Planning and Surgical Technique Guide MANUAL PEG AND KEEL PREPARATION Prerequisites The manual resection of the RESTORIS MCK
12. grit blasted Onlay Insert Foil inner pouch Prior to sealing environmental oxygen air is purged with inert gas Impermeable preventing re entry of oxygen Tyvek Mylar outer pouch Onlay Baseplate Tyvek Mylar inner and outer pouches Gamma 2 5 4 0 Mrad 47 Patella Ultra high molecular weight polyethylene UHMWPE per ASTM F648 GUR 1050 resin type 2 Compression molded Machined from stock material Foil inner pouch Prior to sealing environmental oxygen air is purged with inert gas Impermeable preventing re entry of oxygen Tyvek Mylar outer pouch RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand RESTORIS MCK Planning and Surgical Technique Guide Femoral Condyle Technical Data Condylar Distal Posterior Peg1 Peg2 Peg Keel Height Thickness Thickness Height Height Diameter Height 3 ao wo xs so se om no es on 3 aso mo mi 45 e or zo es 00 Size AP ML s su 9 ws a es wo wo es 18 s ss mo e s ee mre wo es 20 7 ss mo ma ss ro o o es 25 e eso ao ws ss 72 ua o es 30 All dimensions in mm Ea Posterior Thickness Peg Diameter S Peg 2 Height P Peg 1 Height Condylar Height 48 RESTORIS MCK Planning and Surgical Technique Guide Tibial Inlay Technical Data Size AP M Thickness L 8 49 xe 75 95 All dimensions in mm
13. in Primary view and scroll through the slices or use the Verify 1 and Verify 2 preset views to verify planning criteria Patellofemoral Trochlear Intra Operative Cartilage Mapping Map 5 cartilage points along the deepest point of the trochlear groove most anterior to most distal C Map 2 points at medial and lateral superior edge Map 3 cartilage points along each of the medial and lateral transition edges RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 19 RESTORIS MCK Planning and Surgical Technique Guide Patellofemoral Trochlear Intra Operative Planning Summary View View View Verify 1 Primary Verify 2 Ensure medial Move AP to ensure Adjust F E of Trochlear tip rests on in implant is split midway component to best bone surface match 1 mm 3 most anterior trochlear groove points by bone mapped surface View Primary Move Trochlear viv and Si Note if the mapped Ensure distal tip is anterior to to best match 1 mm points lie on arthritic bone Blimencante ine lateral cartilage transition and not cartilage adjust region F E to be 2 mm proud of View bone surface Verify 2 RESTORIS MCK Femoral Component Intra Operative Planning Summary Set Femoral anterior tip just proud of bone below PF wing pest match Femoral Medel edge and or slightly inset to cartilage to condylar curvature inset from medial edge 1 2 mm j Best
14. match Femoral High Point Adjust Femoral to obtain Groove to Tibial trace points from desired joint balancing gap Joint Balancing Pose Capture 0 1 5 mm looseness 76 Planning and Surgical Technique Guide Intra Operative Planning Tn TI oss 8 Ld al cRe Poly Thickness 8 0 mm Joint Balancing PreResection Extension Poly Thickne SOmm Joint Balancing PreResection J PreResection LA PreResection Gap Tight Le j z Tight Loos Adjust femoral SI to set desired extension gap Flexion Poly Thickness 8 0 mm Joint Balancing PreResection 7 Flexion Gap Poly Thickness 8 0 mm 7 Joint Balancing PreResection ProResection V PreResection Tight Loos Adjust femoral AP Tight uMMEEMEMEMEEEE EEMEEEE to set desired NE flexion gap SAGITTAL 6 2 Flexion Flexion TT RESTORIS MCK Planning and Surgical Technique Guide Poly Thickness 8 0 mm Joint Balancing PreResection Mid Flexion M PreResection Flex the implant slightly to increase the gap in mid flexion gt Extend the implant slightly to decrease the gap in mid flexion Flexion Flexion Quick Fit Overview Quick Fit optimizes the placement of the Femoral Condyle component in the sagittal plane anterior posterior translation superior inferior translation and optionally flexion extension rotation using the inputs from the captured poses from Joint Balancing and the desired gap values entered in
15. quadriceps and increase the risk of lateral subluxation Figure 26 While holding the Drill Guide Assembly firmly in place drill the three peg holes using the Patellar Tibial Peg Drill making sure the drill stop collar contacts the top of the Patella Sizing Drill Guide Figure 26 Remove the Drill Guide Assembly and any loose material from the patella Place the Patella Trial onto the resected patella Use the Patella Calipers to reassess the patella thickness Figure 27 If the overall thickness is greater than the original patella bone thickness consider shaving off additional patella bone Perform manual range of motion check to ensure proper patella tracking and patella transitioning Remove the Saw Guide Jaw from the Patella Clamp and insert the blue Cement Clamp Body to create a Cement Clamp Assembly Figure 28 Apply cement to the resected patella surface drilled peg holes and Patella Implant while the cement has a doughy consistency Place the Patella component onto the resurfaced patella Figure 28 45 RESTORIS MCK Planning and Surgical Technique Guide Fully open the jaws of the Cement Clamp Assembly and align the Cement Clamp Body onto the articular surface of the Patella Implant and Clamp Jaw teeth to the anterior surface of the patella Close the Cement Clamp Assembly around the patella and turn the knob tensioner to apply an adequate clamping force Figure 29 Ensure that the Patella Imp
16. the trochlear groove entrance by 0 6 mm 5 flexion 5 extension SI bone line splits implant Varus ui a Flexion e Pre Operative Patellofemoral Planning Fit Select PF Primary Fit anterior shape If desired adjust I E to roughly match the anatomy If Internal rotation is used ensure that the lateral PF ridge is not proud of bone For lateral dysplasia try to maintain 1 mm of lateral Internal proudness without going EA into external rotation ED m gt Fit proximal lateral tip r Move AP so that the Display Axas proximal lateral tip of PF is split midway by the bone surface Extension 1 0 65 Planning and Surgical Technique Guide Pre Operative Patellofemoral Planning Fit Select PF Primary Fit distal tongue Adjust V V and ML to best match patellar transition zones shape to bone shape Adjust SI so patellar transition zones are 2 mm proud of bone surface Select PF Verify 2 Verify ACL notch Adjust F E so that the trochlear groove of the implant is 2 mm proud of bone Verify that distal tongue does not violate the intercondylar notch and cause ACL impingement PF distal tip should be anterior to Blumensaat s line Internal 4 0 Valgus 2mm proud 2 Extension 2 0 1 0 4 Internal 4 0 Extension 1 0 66 Back Next gt lt ize Select Proud 20mm qmm All Implants Display Axes RESTO
17. to enable proper patella retraction for femoral prosthesis insertion femoral registration and tibial registration Inspect all compartments and evaluate the integrity of the Anterior Cruciate Ligament ACL and Posterior Cruciate Ligament PCL to confirm the indications for a unicondylararthroplasty Elevate the medial capsule from the proximal tibia to the mid sagittal plane For an Inlay procedure this may not be required because less tibial exposure is needed A medial collateral release should not be performed Debulk the fat pad as needed for exposure and resect the visible medial meniscus Reflect patella laterally to expose tibiofemoral joint space Trim any portions of loose or torn meniscus and release soft tissue from the anterior surface of the tibia as needed for improved exposure and registration RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 17 RESTORIS MCK Planning and Surgical Technique Guide Lateral Incision and Exposure 1 With the knee flexed at about 45 create a skin incision directly over the median plane of the knee as lateral soft tissues are extremely thin The underlying arthrotomy will be placed more laterally than the skin incision to prevent wound complications As a guide for a minimally invasive technique the incision should extend from the superior pole of the patella to approximately 2 cm below the tibial plateau Extend the incision proximally or distal
18. within 5 flexion of the pre resection pose the Pre resection gap value recorded during Joint Balancing is displayed Click Capture Gap to record the gap for a given flexion angle in the bar graph To compare post resection gaps to pre resection gaps it is best to obtain joint gaps within 5 flexion of the pre resection poses However there is no limitation on how many post resection 82 RESTORIS MCK Planning and Surgical Technique Guide gaps can be obtained but flexion angles are limited to those collected during contact poses For most accurate results capture the gap when the knee is within 5 of axial rotation of the contact pose Adjust the axial rotation of the knee until the rotation bar is within the 5 delta window The delta window will turn to a different color when within the proper range If the gap values are larger than desired changing the Poly thickness in the drop down menu after Capture Contact can be used to predict the effect of a thicker trial implant x The gap value should not be negative unless axial rotation was excessively outside that taken during pre resection or if the trials implants were not touching during contact pose captures The post resection gap may be less or greater than the pre resection value if the varus valgus moment is not the same as in pre resection if there are joint changes due to bone resection such as release of capsular adhesions and or additional osteophyte rem
19. Bicompartmental Incision and Exposure 1 With the knee flexed at about 45 create a skin incision directly over the median plane of the knee The underlying arthrotomy will be placed more medially than the skin incision to prevent wound complications As a guide for a minimally invasive technique the incision should extend from the superior border of the patella to approximately 2 cm below the tibial plateau Extend the incision proximally or distally as needed for adequate visualization Undermine the subcutaneous tissues and place retractors to expose the medial retinaculum Make a medial sub vastus or mid vastus arthrotomy through the medial retinaculum capsule and synovium The length of the incision and arthrotomy must be sufficient to enable proper patella retraction for femoral prosthesis insertion femoral registration and tibial registration Inspect all compartments and evaluate the integrity of the Anterior Cruciate Ligament ACL and Posterior Cruciate Ligament PCL to confirm the indications for a unicondylar arthroplasty Elevate the medial capsule from the proximal tibia to the mid sagittal plane For an Inlay procedure this may not be required because less tibial exposure is needed A medial collateral release should not be performed Debulk the fat pad as needed for exposure and resect the visible medial meniscus Reflect patella laterally to expose tibiofemoral and patellofemoral joint space Trim any portions o
20. Cotors Soren Hecke 2 het Veer Lateral Remar rmary 7 EE Fladen d P lar A f nec ta Quake Fa Map Ch ir karitu aca Fen arte ar Domalive side left Loose 1 3mm Tip distance 1 3 mm Flexion i i 89 RESTORIS MCK Planning and Surgical Technique Guide APPENDIX C RESTORIS MCK lateral Unicondylar Implant Planning Pre Operative Sequence his is the recommended procedural sequence n l 1 Drag from Default location to approximate e This sequence was designed to limit the location number of times switching between Size repeat above step if size changed components Fit rotate and translate e The sequence can be performed in a Verify fit different order but additional component adjustment may be necessary Femoral Drag from Default location to approximate location if necessary Verify size re drag if size changed Fit rotate and translate Verify fit 90 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Tibial Component Pre Operative Planning Summary 3 mm proud of bone note for the Inlay do not inset more than 3 5 mm below cortical bone surface Onlay maximize cortical coverage without overhanging Slightly internally rotated with respect to tibial Inlay maintain offset of 2 3 eminence ridge mm from cortical rim Medial edge does not Onlay best match baseplate intrude into tibial perimeter with cortical rim eminence Inlay best match inla
21. Gap Settings or Surgeon Preferences 1 Quick Fit is only available when the Femoral Condyle plan is active t Upon clicking Quick Fit the Femoral Condyle placement and graph are automatically updated Desired Gap Settings Desired gap values for extension mid flexion and flexion can be set in Gap Settings or Surgeon Preferences The gap values for each flexion range can vary from 5 mm to 5 mm in 0 5 mm increments Quick Fit will attempt to achieve all desired gap setting values within their tolerance settings The tolerance settings for extension mid flexion and flexion are 0 25 mm 1 mm and 0 25 mm respectively For example if the desired extension gap is set to 1 mm Quick Fit may provide an output where the extension gap is 0 75 1 25 mm 78 RESTORIS MCK Planning and Surgical Technique Guide Since extension and flexion gaps are of primary concern to surgeons these tolerances were set narrower than the mid flexion tolerance a If Quick Fit cannot find a solution that meets all the desired gap values set by the 1 user a warning will be displayed indicating that the gap value for the indicated pose is outside the desired gap range Captured Pose Ranges The extension and flexion pose target angles can be set to a value within 5 25 and 80 150 of flexion respectively The extension and flexion pose angle ranges are defined as 5 of the target value so the possible extension range is 0 30 flexion and the poss
22. Inlay throughout the entire curing process RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 38 RESTORIS MCK Planning and Surgical Technique Guide Tibial Inlay 1 component prior to the Tibial component 4 To facilitate component insertion it may help to insert the Femoral Condyle Insert the selected size Tibial Inlay Trial Figure A Correct assembly of the Tibial Figure B Proper impaction technique when Impactor Ensure that the Baseplate Inlay using the Tibial Baseplate Inlay Impactor Impactor Head is completely snapped onto the Impactor Handle before use With the applicable Femoral Trial in place move the knee through a full range of motion Remove the Tibial Inlay Trial component Use high pressure pulsed lavage right angle attachment works well or similar technique to remove fatty deposits from the cancellous porous structure Dry the surface with a sponge filling the cavity under firm digital pressure or similar technique prior to cementing The open porous structure improves cement interdigitation A wet cloth may be placed behind the tibia to catch escaping cement during impaction Immediately apply cement to the resected cavity using a cement gun or firmly pack the cement into the bone using your fingers Cement should be inserted as soon as it becomes workable not shiny and sticky Apply cement to the Inlay bottom and peripheral cement channel Immed
23. RESIORIS MCK Planning and Surgical Technique Guide 206591 15 Rev 00 MAKO SURGICAL CORS This page intentionally left blank RESTORIS MCK Planning and Surgical Technique Guide Table of Contents gy ipli euge Meum mM EC S 1 Rizkllell4 gp 90 cC OPE tc 3 INDICA HONS FOR USE isesi aa aE QUEEN EU EEE aie 4 CONTRAINDICATION S sisira a 5 PATIENT SELEG TIOE oe S 6 WARNINGS AND PRECAUTIONS eeeeeeeeeeeeeeennn nennen nnn nnn nnn 7 IMPLEMENTATION USING RIO eeeeeeseeeeeeereeeneeennennn nnne 8 INSTRUMENTATION aassmesvetuud RIED NI IUE DEAN UE BINE PIPER PME 8 PRE OPERATIVE IMPLANT PLANNING eene 9 BONE PIN PLACEMENT eee nme HEU PI RIVE e eee eee nO dd Rei 17 INCISION AND EXPOSURE i ecostsxintEskupiRuEiaxti ex K pan Eu pK ERR REV NM RES QU FE RN Ud CNN FAR Enn 17 PRE RESECTION JOINT BALANCING 1eeeeeeennenene nnne 20 INTRA OPERATIVE IMPLANT PLANNING eere 22 BONE PREPARATIDDBI s ssesut VervodqPPHFEIORu ver cessenss vacsouvensnessradbeosacediapsecapesnnearonesnas 25 MANUAL PEG AND KEEL PREPARATION eere 28 TRIAL REDUCTION AND IMPLANTATION eeereneeeennnn n 32 PATELLA PREPARATION ies spib SUME IMMUNE NUMEN IMUND ene dM UN UI NM ULOE 42 RESTORIS MCK TECHNICAL DATA eene nennen nennen 47 lug ci Pp S C ens
24. RIS MCK Planning and Surgical Technique Guide Pre Operative Patellofemoral Planning Verify Fit Select PF Verify 1 3 Verify fit of proximal medial tip Verify medial tip of PF rests in or on red bone surface does not need to be split by red bone surface If the medial tip rests off bone translate PF posterior to rest on bone surface 67 Planning and Surgical Technique Guide Femoral Component Pre Operative Femoral Planning Default Position Size and position are based on Bicompartmental planning Select Medial Femur Primary Crosshair automatically positioned at flexion facet center near posterior peg tip Internal E 3D view set to Transverse 3 0 Distal All Implants Display Axes Flexion 0 0 Femoral Planning Recommended Positioning Limits Femoral Condyle 5 internal 5 external AP 1 mm proud of bone 3 varus lt gt 3 valgus ML centered on condyle 5 flexion 5 extension SI 1 mm proud of bone All Implants Display Axes Pre Planning Flexion 0 0 68 Pre Operative Femoral Planning Fit Match medial condylar curvature of bone Adjust I E to match condylar curvature excluding osteophytes Adjust ML to centralize condyle and to be 1 2 mm inset from medial edge Adjust V V to match PF component Do not try to match component shape with arthritic bone shape using V V Match J curve
25. Tibia Verify 2 Proud G 30mm All Implants Display Axes RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 61 Planning and Surgical Technique Guide Bicompartmental Component Pre Operative Bicompartmental Planning Default Position Component is imported in Default location Size 5 is Default size Select Bi Comp medium Crosshair automatically positioned through largest AP section Largest AP length Upside down Frowny Face Patella transition distal corona FAL implants tongue of PF E m of PF Fish TF 3D view set to Transverse Distal Patellofemoral 5 Femoral Condyle M 27 Extension 0 0 Drag Bicompartmental so that medial side of PF is approximately 1 mm proud of red bone surface Drag Bicompartmental so that PF tongue is split midway by red bone surface 62 RESTORIS MCK Planning and Surgical Technique Guide Pre Operative Bicompartmental Planning Size O pene sizing Based on AP medial bone length deal Bicomp size Anterior medial PF 1 mm proud of bone Posterior Condyle 2 mm inset or 1 mm proud f Posterior Condyle 22 mm inset upsize 21 mm proud downsize Note some internal rotation might be required to assess size All Implants Display Axes f size changed re drag component to correct location Patellofemoral 3 Femoral Condyle M 63 Plannin
26. Tibial Keel Patellofemoral Surface Patellofemoral Post 1 Patellofemoral Post 2 Patellofemoral Post 3 RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 25 RESTORIS MCK Planning and Surgical Technique Guide Table 1 Resection Steps for RESTORIS MCK All steps marked with an X are to be completed with the 6 mm Ball Burr Unicondylar Unicondylar Patellofemoral Bicompartmental Bicompartmental Uni Inlay Uni Onlay Inlay Onlay Patella R 3 Manual Manual Manual atella Resection Preparation Preparation Preparation Notes 1 Femoral keel resection is only applicable to sizes 3 8 2 The Tibial Onlay Keel may be prepared in a medial or lateral procedure by impacting the Tibial Onlay Trial however RIO access for a lateral unicondylar procedure can be challenging so using the trial is the recommended method of lateral keel resection 3 Preparation of the patella uses the Patella Preparation Section of this manual 4 The Tibial Inlay has a surgeon preference setting that allows resection with Figure 8 or without Figure 7 the clover pattern boundary Using the clover pattern leaves four small sections of bone that fit closer to the Inlay component to help stabilize the Inlay Trial and Implant during cementing Figure 7 RESTORIS MCK Inlay Resection Figure 8 RESTORIS MCK Inlay Resection WITHOUT Clover Pattern WITH Clover Pattern RESTORIS MCK Inlay component is not approved
27. a a m n m wr 5 4 X Eu ae a Use pulsed lavage or similar technique to remove fatty deposits from the cancellous porous structure and pat dry A wet cloth may be placed behind the tibia to catch escaping cement during impaction Apply cement to the Tibial Baseplate ensuring excessive cement is not applied posteriorly Apply cement to the resected tibia and firmly pack the cement into the bone using your fingers Place the Tibial Baseplate onto the tibia and impact with the Inlay Baseplate Impactor starting posteriorly and work anteriorly allowing cement to escape anteriorly Impact vertically into final position Confirm that the implant is fully seated Carefully remove all excess extruded cement If a wet cloth was used posteriorly remove it Place Onlay Insert Trial into the Tibial Baseplate implant With the Femoral Condyle centrally loading the Onlay Insert Trial hold the knee joint stationary until cement has cured With cement cured on the Femoral and Baseplate Implants move the knee through a full range of motion to ensure desired insert thickness is trialed RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 36 RESTORIS MCK Planning and Surgical Technique Guide 14 Remove Onlay Insert Trial see figures in step 3 Verify that the surfaces and walls of the Baseplate are free of soft tissue cement remnants and any other obstruction t Check the Onlay Insert alignment with t
28. articular surface is flush with the bone RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 23 RESTORIS MCK Planning and Surgical Technique Guide Implant Planning After Initial Resection Care must be taken when choosing to adjust an implant plan after resection has taken place Since the software tracks only the latest change to an implant plan a plan can be created which overlaps a previous resection To prevent implant malalignment or component impingement the operative surgeon should check component placement with the RIO probe before a change to the plan is made Any component can be re planned and or resized and subsequently resected again after an initial resection using any of the implant planning features The following issues should be considered before changing a component plan after initial resection e Any system configuration Unicondylar Patellofemoral or Bicompartmental The software will not save the previous plan once a change to the plan is made The old plan will be overwritten The undo button may be used but only the latest new plan will be applied when returning to the Bone Preparation page Any change which causes the implant to become more proud of the bone will not be represented in the software i e resected bone cannot be restored Aconversion from Tibial Inlay to Onlay will align the initial Tibial Onlay plan with the articular surface of t
29. aumatic arthritis of the tibiotemoral and or patellofemoral articular surfaces a The indication above regarding the use of RESTORIS MCK Uni for revision of The specific knee replacement configurations include e Medial unicondylar e Lateral unicondylar e Patellofemoral e Medial bi compartmental medial unicondylar and patellofemoral RESTORIS MCK is for single use only and is intended for implantation with bone cement RESTORIS MCK Planning and Surgical Technique Guide CONTRAINDICATIONS RESTORIS MCK Uni and RESTORIS MCK PF RESTORIS MCK Uni or PF is contraindicated in patients with greater than 10 of hyperextension greater than 10 of varus or valgus deformity Unicondylar only with active infection with either mental or neuromuscular disorders that do not allow control of the knee joint whose weight age or activity level might cause extreme loads and early failure of the system without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis without sufficient soft tissue integrity to provide adequate stability RESTORIS MCK Bicompartmental The use of RESTORIS MCK Uni and RESTORIS MCK PF simultaneously for multi compartmental knee replacement is contraindicated in patients with greater than 10 of hyperextension greater than 10 of varus or valgus deformity with active local infection or previous intra articular infection with neuropathic Charcot joint with cruciate and
30. ay within positioning limits Inlay adjust to be slightly less than tibial varus slope Adjust ML to avoid intrusion into the tibial eminence and Onlay avoid overhang Inlay 2 3 mm inset from cortical rim Select Medial Tibia Primar Proud 3 0 mm All Implants Display Axes Pre Operative Tibial Planning Fit Adjust I E to align edge of component with tibial intercondylar eminence edge and to avoid PCL notch Note ignore anterior bone when assessing I E rotation RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 60 Pre Operative Tibial Planning Verify Fit Select Medial Tibia Verify 1 Re adjust proudness to 3 mm if necessary Onlay Verify implant rests on cortical rim and does not interfere with eminence Inlay Verify implant is 2 3 mm from cortical rim not including osteophytes To maintain subchondral bone plate do not inset 23 5 mm below cortical surface Note some bone might be proud at anterior tip Select Medial Tibia Verify 2 Onlay Verify implant does not overhang AP amp ML Scroll through slices as necessary to ensure proper fit Internal Inlay 1 0 Verify implant is 2 3 mm from cortical rim not including osteophytes Scroll through slices as necessary to ensure proper fit t C a at pr Valgus UT Planning and Surgical Technique Guide Options Screen Help Select Medial
31. be adversely influenced by effects of the osteoarthritic pathology e g osteophytes capsular adhesions and osteochondral defects Osteophytes interfering with Medial Collateral Ligament or Lateral Collateral Ligament for lateral UKA function should be removed and capsular adhesions interfering with knee function should be relieved With these impediments removed it will be possible to achieve correct knee kinematics and tissue tension during passive manipulation throughout the full range of motion Pre Resection Joint Balancing To achieve correct restoration of the osteochondral defects joint balancing pose capture must occur with the collateral ligament properly tensioned Doing so will provide correct bone spacing extension and flexion gaps during Intra Op Implant Planning such that after resection and component implantation knee mechanics will be properly restored throughout leg range of motion Although this step is referred to as Joint Balancing desired joint balancing is achieved in Intra Op Implant Planning using the data gathered in this step bone spacing with properly tensioned ligaments 20 AN A a a RESTORIS MCK Planning and Surgical Technique Guide Ensure osteophytes are removed prior to taking pose captures for Joint Balancing Attempt to apply the appropriate varus or valgus valgus medial varus lateral moment to the tibia at each pose during Joint Balancing for proper tensioning of ligaments
32. collateral ligament insufficiency with skeletal immaturity with either mental or neurologic conditions that do not allow control of the knee joint or that tend to preempt the patient s ability or willingness to restrict activities without sufficient soft tissue integrity to provide adequate stability without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis whose weight age or activity level might cause extreme loads and early failure of the system RESTORIS MCK Planning and Surgical Technique Guide PATIENT SELECTION Selection of multicompartmental knee replacement depends on the judgment of the surgeon with regard to the requirements of the patient The surgeon should become thoroughly familiar with the technique of implantation for multicompartmental knee surgery by 1 appropriate reading of the literature and 2 training in the operative skills and techniques required for multicompartmental knee replacement surgery MAKOplasty procedure The effectiveness of all knee implants can be reduced by The operative surgeon has final decision authority in choosing recipients of the poor patient selection Additional Patient Selection Guidelines Considerations e Articulation of the hip joint is necessary to complete bone registration e Metal in the operative or non operative leg can lead to the creation of accuracy reducing artifacts in the CT scan which can adversely affect the operative plan e The
33. complete Patellofemoral Planning Appendix B describes the steps necessary to complete a Bicompartmental Inlay Onlay only the steps specific to a Patellofemoral procedure are relevant Planning Sequence e Patellofemoral Trochlear Ensure the Patellofemoral Trochlear component is not in excessive external rotation or valgus as these will decrease the lateral patella jump height and increase the risk of lateral patella subluxation The proximal edge of the Patellofemoral Trochlear component can transition into the bone in three ways Proud the articular surface is proud cemented surface rests on top of the bone Medium halfway between proud and flush Flush the articular surface is flush with the bone Bicompartmental Intra Operative Planning For details regarding the following steps refer to Appendix B for a step by step procedure to complete Bicompartmental Planning Planning Sequence e Tibial Inlay Onlay e Patellofemoral Trochlear e Femoral Condyle Medial Ensure the Patellofemoral Trochlear component is not in excessive external rotation or valgus as it will decrease the lateral patella jump height and increase the risk of lateral patella subluxation The proximal edge of the Patellofemoral Trochlear component can transition into the bone in three ways Proud the articular surface is proud cemented surface rests on top of the bone Medium halfway between proud and flush Flush the
34. d i Tip distamoe 3 3mum NOTE For better visualization set Implant View to Tibia Primary and turn on All Implants to cycle through the flexion angles and watch the actual tracking of the femoral component on the tibia component 104 RESTORIS MCK Planning and Surgical Technique Guide Intra Operative Femoral Planning Fit 2 Adjust V V if necessary Some valgus may be necessary to match posterior condylar curvature 3 Adjust F E AP and SI to obtain desired joint balancing gap Goal 0 1 5 mm looseness in graph If mid flexion gap is tight flex Femoral If mid flexion gap is loose s grm extend Femoral Ah 1 Tip diane 13r Excessive flexion may make it more difficult to insert the Femoral trial or Femoral Implant NOTE If Quick Fit is enabled use Quick Fit atthis time Intra Operative Femoral Planning Verify Fit E Select Lateral Femur T Verify 1 hat OLO Anterior tip of Femoral component should not be proud of the mapped cartilage surface External Excessive anterior recessor ial proudness could cause Ps patella tracking problems ER XN cerno f Loose i Seren un CET 1 3mm 105 A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient Stryker does not dispense medical advice and recommends that surgeons be trained in the u
35. d below cartilage Peer reviewed literature suggests that recessing the anterior tip does not affect UKA outcomes 1 2 However additional warnings will be displayed if the tip is excessively recessed approximately 5 mm deep or excessively proud gt 3 mm proud 19 RESTORIS MCK Planning and Surgical Technique Guide The surgeon then must exercise good medical judgment if changes need to be made to the implant plan References 1 Simultaneous In vitro Measurement of Patellofemoral Kinematics and Forces Following Oxford Medial Unicompartmental Knee Arthroplasty A Price PT Oppold DW Murray AB Zavatsky Journal of Bone and Joint Surgery Br 2006 88 B 1591 1595 Price et al In vitro measurement of PF kinematics and forces following Oxford medial UKA JBJS Br 2006 2 The influence of the presence and severity of pre existing patellofemoral degenerative changes on the outcome of the Oxford medial unicompartmental knee replacement Beard DJ Pandit H Gill HS Hollinghurst D Dodd CA Murray DW Journal of Bone and Joint Surgery BR 2007 Dec 89 12 1597 601 Since each patient has a unique cartilage thickness near the anterior tip of the Femoral Condyle component it is recommended that the surgeon maps the cartilage t surface near the anterior tip to avoid patella impingement If the anterior tip is proud of the cartilage after Quick Fit the surgeon can manually make adjustments to the implant plan to achieve the desired placemen
36. eeen antes 53 APPENDIX 71 uc Ro fc O P 90 This page intentionally left blank RESTORIS MCK Planning and Surgical Technique Guide INTRODUCTION A RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand User Manual Terms of Use This manual is provided by MAKO Surgical Corp MAKO and may be used for informational purposes only Terms and Conditions related to the use of the Robotic Arm Interactive Orthopedic System RIO can be found in the MAKOplasty agreement with the system user About This Manual This manual describes design considerations patient selection implant planning and surgical techniques for implantation of the RESTORIS MCK implant system using both manual instrumentation and assisted by the Robotic Arm Interactive Orthopedic System RIO The latter procedure will be identified as MAKOplasty in this manual Manufacturer Support Feedback MAKO Surgical Corp 2555 Davie Rd Ft Lauderdale FL 33317 Corporate Office Phone 1 954 927 2044 Corporate Office Fax 1 954 927 0446 makosurgical com Medical and Product Information This manual is informational only and is not intended as medical advice or a substitute for medical advice As the manufacturer of medical devices in the field of orthopedics MAKO does not practice medicine and does not recommend the surgical techniques referenced or discussed
37. ella component 4 RESTORIS MCK Bicompartmental Inlay Medial only e RESTORIS MCK PF MCK Uni Inlay 5 RESTORIS MCK Bicompartmental Onlay Medial only e RESTORIS MCK PF MCK Uni Onlay Sizes All sizes are outlined in the RESTORIS MCK Implant Technical Data section of this manual INSTRUMENTATION Two instrument trays a Unicondylar and a Patellofemoral tray are available for use with the RESTORIS MCK Implant System Each tray contains instrumentation and implant trials specific to implementation of that procedure Both trays are required when performing a RESTORIS MCK Bicompartmental Inlay or Onlay procedure All RESTORIS MCK implants require the use of the RIO therefore a Standard MAKOplasty Instrument Set is also required RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand RESTORIS MCK Planning and Surgical Technique Guide PRE OPERATIVE IMPLANT PLANNING The primary purpose of pre operative planning for the RESTORIS MCK implant system is implant sizing and alignment to bone anatomy Fine tuning of the component position and orientation based on patient specific biomechanics and cartilage thickness will be completed during the intra operative steps Refer to the RIO System User Guide PN 203857 15 and MAKOplasty Partial Knee Application User Guide PN 206388 15 for software control details the mechanical axis of the applicable bone Internal External rotations are with All varus valg
38. er fit Internal 0 9 CORONAL e Posterior Slope 5 0 Planning and Surgical Technique Guide Options Screen Help BP RESTORIS MCK Lateral Onlay UKA Size Select Proud Flexion 13 0 Loose 1 8 mm Please confirm plan Size Select Proud Flexion 13 0 Loose 1 8 mm Please confirm plan RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 103 RESTORIS MCK Planning and Surgical Technique Guide Femoral Component Lateral Unicondylar Intra Operative Femoral Planning Verify Size Meniscal Notch Select Lateral Femur EA El i p T A XL A j j x Primary Verify component size Ideal size is when anterior tip is approximately aligned with meniscal notch in Internal 3D view and best 0 9 matches femoral J curve ese Late a rrens Pg i Map cartilage points in ot transition region to M room ensure smooth patella m Lense 1mm handoff t Tie distance 1 irim Intra Operative Femoral Planning Fit Adjust I E and or ML to In align Femoral High Point Groove to Tibial trace points as best as possible This will aid in central Tibial component loading The Femoral High Point Groove is the probable tibial tracking pathway If implant alignment and implant tracking are in conflict preference should be given to i anatomic implant oc Peete alignment
39. f loose or torn meniscus and release soft tissue from the anterior surface of the tibia as needed for improved exposure and registration RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 19 RESTORIS MCK Planning and Surgical Technique Guide PRE RESECTION JOINT BALANCING Philosophy For manual medial unicondylar implantation it is typical for the surgeon to evaluate post resection restoration by insuring the femoral tibial gap and limb alignment are acceptable in extension flexion and for intermediate leg poses while inducing an appropriately applied valgus stress During a MAKOplasty ligament tension and limb alignment can be established prior to resection and implantation by capturing the leg in corrected poses and tension such that the final implant placement will achieve the desired result In other words with precise planning prior to resection it is possible to achieve proper ligament tension and limb alignment after implantation Joint Balancing is not necessary for a Patellofemoral only procedure because the tibia is not registered bone during Joint Balancing See the MAKOplasty Partial Knee Application User Either the tibia or the femur can be fixed while the other moves relative to the fixed j Guide PN 206388 15 for instructions on setting this in Surgeon Preferences Eliminate Osteophyte Adhesion Effects on Joint Mechanics The Pre Resection Joint Balancing data must not
40. g impacting a trial or implant If the initial fit is too tight impaction could damage the bone Return to the BONE PREPARATION section if more bone must be removed Do not place excessive off center shear loads on the implant component until the cement has cured These types of loads could cause improper implant to cement to bone fixation and could shorten implant life For proper fixation the knee must be kept stationary while cement cures If the leg is moved during curing the implant components may move from their intended positions Multiple cement batches should be used when cementing multiple implants to maintain a consistent and suitable cement viscosity that 1 enables all implants to fully mate to resected bone to ensure desired alignment 2 enables sufficient cement interdigitation into the cancellous bone to ensure proper fixation and 3 enables the user to apply an even distribution of compressive force to ensure the implant remains stable while the cement is setting 32 RESTORIS MCK Planning and Surgical Technique Guide Femoral Condyle 1 2 Insert the selected size Femoral Trial impact as applicable Figure A One Piece RESTORIS MCK Figure B Proper impaction technique when Femoral Impactor using the Femoral Impactor Align impactor with Trial Implant Peg axis Rongeur any proud cartilage and bone component prior to the Tibial component a To facilitate component insertion it may help to inse
41. g and Surgical Technique Guide Patellofemoral Trochlear Component Pre Operative Patellofemoral Planning Default Position Size and position are based on Bicompartmental planning Select PF Primary Crosshair automatically positioned Widest section of PF Mad Face Patella transition distal tongue of PF Proximal lateral tip solid lateral sphere 3D view set to Transverse Distal Verify PF size Ideal PF size is the largest that does not overhang the bone ridges no more than 2 mm inset on either side ensuring it does not interfere with the ACL not including osteophytes If size changed re select PF Primary and move to correct location Proud 2 6 mm ndo nee et All Implants Display Axes Extension 0 0 Size Select Proud 2 6mm All Implants Display Axes Flexion 6 64 Planning and Surgical Technique Guide Patellofemoral Trochlear Recommended Positioning Limits Options Screen Help Patellofemoral Trochlear 4 internal e 0 external AP 2 mm proud of bone at the trochlear groove Sica vice Select Every degree of internal rotation medializes the trochlear groove 0 5 mm and raises the Internal patella jump height 0 3 mm 3 varus lt gt 2 valgus Proud 26mm qmm ML centered on notch ya All Implants e g Every degree of V V Display Axes rotation translates
42. g instructions are only applicable if those views are not altered 53 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Implant Planning Pre Operative Sequence his is the recommended procedural oequence Mo uu Drag from Default location to approximate e This sequence was designed to limit the location number of times switching between Size repeat above step if size changed components Fit rotate and translate e The sequence can be performed in a Verify fit different order but additional component adjustment may be necessary to avoid intercomponent impingement Bicompartmental e Drag from Default location to approximate location Size repeat above step if size changed this step aids in initial Patellofemoral and Femoral sizing Patellofemoral Trochlear Drag from Default location to approximate location if necessary Verify size re drag size if changed Fit rotate and translate Verify fit Femoral Drag from Default location to approximate location if necessary Verify size re drag size if changed Fit rotate and translate Verify fit 54 RESTORIS MCK Planning and Surgical Technique Guide Implant Planning Abbreviations AP Anterior Posterior ML Medial Lateral SI Superior Inferior same as Proximal Distal V V Varus Vargus F E Flexion Extension I E Internal External PFJ Patellofemoral Joint procedure UKA Unicondylar Knee Arthroplasty procedure
43. he Tibial Baseplate before impacting 15 Secure the posterior locking mechanism of the Onlay Insert under the posterior capture feature of the Tibial Baseplate A correctly positioned Insert will have its front edge parallel to the top edge of the Baseplate pocket as illustrated in Figure 17 Figure 17 In this position the anterior chamfer of the Insert should align with the corresponding pocket chamfer of the Tibial Baseplate as shown by the cross section view in Figure 18 Figure 18 To avoid slippage of the Onlay Insert use only the Onlay Insert Impactor for impaction 37 RESTORIS MCK Planning and Surgical Technique Guide Note that an incorrectly positioned Insert will have its front edge at an acute angle with the top edge of the Baseplate pocket as shown in Figure 19 In this scenario the Insert must first be positioned correctly before proceeding 16 With the Insert correctly positioned use the Onlay Insert Impactor at a 30 45 angle to impact the anterior edge of the Insert and lock it into the Tibial Baseplate The impaction should be sharp enough to fully seat the Onlay Insert with one hit Confirm that the implant is fully seated Figure 19 Figure A One Piece RESTORIS MCK Onlay Figure B Proper impaction technique when Insert Impactor using the Onlay Insert Impactor It may be necessary to mix the cement in multiple batches to ensure that distributed pressure is applied to the
44. he previous Inlay component Detailed instructions on software functionality can be found in the MAKOplasty Partial Knee Application User Guide PN 206388 15 RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 24 RESTORIS MCK Planning and Surgical Technique Guide BONE PREPARATION Even with stereotactic boundaries the burr can contact nearby tissue To avoid risk of serious injury use a retractor to protect the medial or lateral collateral ligament during Tibial Onlay resection To create proper press fit with the implant peg gently plunge the burr only once then release the trigger and move to the next step Plunging more than once can create a larger hole and prevent the peg from fitting snuggly Table 1 is a list of resection steps for each procedure All steps marked with an X are to be completed with the 6 mm Ball Burr others are noted All of the listed steps should be implemented using the technique listed in this manual The order of resection tibial keel router choice and Inlay pattern are surgeon preference combinations that can be adjusted in the Preferences page Table 1 Resection Steps for RESTORIS MCK All steps marked with an X are to be completed with the 6 mm Ball Burr Unicondylar Unicondylar Uni Inlay Uni Onlay Femoral Surface Femoral Post 1 Femoral Post 2 Femoral Keel Tibial Inlay Surface Tibial Onlay Surface Tibial Post 1 Tibial Post 2
45. iately place the Tibial Inlay into the cavity and compress it evenly and forcefully using finger or flat instrument pressure e g freer elevator or the Inlay Baseplate Impactor Carefully remove all excess extruded cement If a wet cloth was used posteriorly remove it RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 39 RESTORIS MCK Planning and Surgical Technique Guide 11 Apply and maintain distributed pressure on the central articular surface of the Inlay This may extrude additional cement which should now be removed Do not allow the implant to move until the cement has fully cured Pressure can be maintained by direct finger compression or with the assistance of the Inlay Baseplate Impactor Distributed pressure is important particularly in the anterior posterior direction to avoid tilting of the component in the sagittal plane within the prepared cavity during cement curing RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 40 RESTORIS MCK Planning and Surgical Technique Guide Patellofemoral Trochlear 1 p 9 Insert the selected size Patellofemoral Trochlear Trial impact as applicable Figure A One Piece MCK Patellofemoral Figure B Proper impaction technique when Impactor using the Patellofemoral Impactor Rongeur any proud cartilage and bone With the applicable Patella Trial in place confirm smooth patella transitioni
46. ible flexion range is 75 155 flexion If multiple poses are taken within the defined range only the pose closest to the target angle will be included in Quick Fit The mid flexion pose range can be within 31 74 of flexion All poses taken within the mid flexion range will be included in Quick Fit 4 Only poses captured within the specified pose ranges are used in the Quick Fit If no poses are taken within the defined ranges clicking Quick Fit will result in a warning instructing the user to take a pose within the indicated range calculations Anterior Tip Fit Literature suggests that femur cartilage thickness near the Femoral Condyle anterior tip is approximately 2 mm but each patient s cartilage thickness is unique and could vary from 1 3 mm thick It is recommended that the surgeon maps cartilage near the anterior tip to ensure that the Femoral Condyle component does not impinge with the patella during knee flexion The distance from the anterior tip to the bone is always displayed in the information box even if cartilage is not mapped Quick Fit will attempt to place the anterior tip of the Femoral Condyle component between 1 mm and 3 mm proud of the bone If the maximum tip distance is greater than 2 mm the information box will display a yellow message advising the surgeon to map cartilage along the anterior tip If proud of the cartilage the surgeon should make manual adjustments until the anterior tip is flush with or recesse
47. icular surface from which the individual component shapes were outlined This aids in inter component alignment and in patella transitioning from the trochlear groove to the femoral condyles during flexion This continuous surface was sectioned into two implant visuals transition zones which act as surface extensions of the Trochlear component The patellar transition zones move with the Trochlear component and can be turned on off The transition zones aid in Femoral positioning and Patella transitioning The transition zones also have a separation indicator wall at 3 mm from the Patellofemoral Trochlear edge which can be used as a reference to ensure that a 3 mm gap is maintained between the Femoral and Patellofemoral Trochlear implants 3 mm Distance Indicators Figure 2 Trochlear transition zones with 3 mm distance indicators 10 RESTORIS MCK Planning and Surgical Technique Guide e Patellofemoral Trochlear Component Geometry The Patellofemoral Component trochlear groove pathway is curved proximally 6 degrees to align with the anatomic axis when implant is planned at 0 degrees varus valgus The visual of the Patellofemoral Trochlear implant contains a Trochlear sulcus groove Figure 3 which is a reference to the potential patella tracking pathway Potential Patella Tracking Pathway Figure 3 Trochlear Visual e Tibial Component Geometry All UHMWPE components have a minimum 6 mm thickness Tibial O
48. in this manual or any other surgical techniques for use on a particular patient MAKO is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient Indications for Use RESTORIS PKA The RESTORIS Partial Knee Application PKA for use with the Robotic Arm Interactive Orthopedic System RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures The RESTORIS Partial Knee Application PKA for use with the Robotic Arm Interactive Orthopedic System RIO is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy These RESTORIS MCK Planning and Surgical Technique Guide procedures include unicondylar knee replacement and or patellofemoral knee replacement Copyrights and Trademarks The content of this manual is protected under applicable copyright and trademark laws You agree that you will not copy distribute republish display post transmit or modify any content in this manual without MAKO s prior permission Any images displayed in this manual are the property of their respective copyright owners Any reproduction replication modification or distribution of any art images in this manual is prohibited
49. is for use when implant surface pockets have been resected and only the pegs and keels need resection or correction No instrumentation exists for resecting RES TORIS MCK surface manually Available instrumentation is applicable to peg and keel resection only Manual Instrumentation The RESTORIS MCK Manual Technique uses the RESTORIS MCK Manual Instrument Set Instruments are provided separately in re usable sterilizable trays Trays include various tools e g templates and drills needed fora RESTORIS MCK manual procedure The steps in this section are guidelines and do not constitute a complete surgical technique 28 RESTORIS MCK Planning and Surgical Technique Guide Femoral Condyle Component Affix the Femoral Template to the resected bone pocket using the Headed Bone Pins and the Pin Pusher Figure 9 Drill the peg holes for the Femoral Condyle Implant using the Femoral Peg Drill Figure 10 Mark the position of the keel using a sterile marker Figure 10 Remove the Headed Bone Pins from the bone using the Pin Puller and remove the Femoral Template Figure 11 Figure 11 29 RESTORIS MCK Planning and Surgical Technique Guide Resect the keel using a 6 mm burr to the depth shown on the Femoral Template Figure 12 Tibial Onlay Baseplate Attach the Onlay Handle to the Baseplate Template Align the Baseplate Template to the resected tibial profile and impact into place with a mallet Confirm tha
50. just these settings for proper placement Quick Fit does not adjust Tibial component placement a As with any optimization the output is only as good as the input If the ligaments are If the Tibial or Femoral Condyle component position or size is changed after Quick Fit has been performed Quick Fit will need to be executed again not properly tensioned and or the limb is not properly aligned during Joint Balancing pose captures Quick Fit cannot be expected to provide a proper clinical outcome Kinematic Analysis Overview During either component trial evaluation or final implant evaluation the Kinematic Analysis page provides the surgeon the ability to quantify post resection limb alignment in extension joint gaps and kinematic range of motion This page also enables the user to compare post resection limb alignment and joint gaps to pre resection values This page is available but not required for completing a MAKOplasty Capture Contact To enable the features in Kinematic Analysis contact poses must first be taken Capture contact poses from full extension to full flexion to record full range of motion Ensure that the trials implants are in continuous contact with each other throughout range of motion When capturing contact poses apply neutral internal external rotation torque on the tibia and let the soft tissue guide its natural motion Contact poses are necessary to zero out the errors due to bone registration over
51. l component size is largest component that will not overhang AP ML and not intrude into tibial intercondylar eminence Inlay Ideal component size is largest component that will be 2 3 mm from cortical rim and not intrude into tibial intercondylar eminence Adjust posterior slope to be slightly less than patient tibial bone slope Removal of meniscus and excessive slope can stress the ACL Adjust proudness to 3 mm Adjust AP as necessary Adjust V V Onlay stay within positioning limits Inlay adjust to be slightly less than patient valgus slope Adjust I E to align edge of component to be slightly internally rotated to intercondylar eminence and to avoid PCL notch RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 102 Intra Operative Tibial Planning Verify Fit Select Lateral Tibia Verify 1 Re adjust proudness to 3 mm if necessary Onlay Verify implant rests on cortical rim and does not interfere with eminence Inlay Verify implant is 2 3 mm from cortical rim not including osteophytes To maintain subchondral bone plate do not inset 23 5 mm below cortical surface Select Lateral Tibia Verify 2 Onlay Verify implant does not overhang AP amp ML Scroll through slices as necessary to ensure proper fit Inlay Verify implant is 2 3 mm from cortical rim not including osteophytes Scroll through slices as necessary to ensure prop
52. l range of motion 3 Remove Tibial Trial components See figures below Figure A Using a Hemostat or similar Figure B Using a Hemostat or similar instrument insert the Hemostat prongs intothe instrument insert the prongs into the removal holes on the anterior edge of the Trial Insert lift holes at the front of the Trial Insert and lift up to up and pull out to extract the Trial get an Osteotome under the trial Grasp the trial firmly and extract the Trial Insert from the Trial Baseplate RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 34 a If using the Onlay Insert Extractor perform the following steps RESTORIS MCK Planning and Surgical Technique Guide Orient the Onlay Insert Extractor so the MAKO logo is visible facing towards the femur and insert the tips of the instrument completely into the holes of the Insert Trial Squeeze the handles of the instrument to lift the Insert Trial from the Tibia Baseplate Keep the Extractor parallel to the Insert Trial Moving the Extractor up or down while engaged with the Trial will damage the Trial DO NOT lever the Onlay Insert Trial from the Tibia Baseplate This may damage the Onlay Insert Trial 35 RESTORIS MCK Planning and Surgical Technique Guide 10 11 12 13 iii Extract the Insert Trial by squeezing the handles and pulling the Insert Trial out of the joint ee 3 wf tm ae P A i x CS mme M
53. lant fully seats onto the patella bone Remove excess cement as needed After the cement has sufficiently cured Figure 29 loosen the knob tensioner and remove the Cement Clamp Assembly Perform a manual range of motion check and verification of implant fixation prior to wound closure 46 RESTORIS MCK TECHNICAL DATA o0 o Q oO O i ou Oo c 3 oO eS 3 c Packaging Shelf Life Sterilization Patellofemoral Femoral Condyle Cobalt chromium CoCr alloy per ASTM F75 Cast heat treated Articular surface polished Cement contacting surface grit blasted Tyvek Mylar inner and outer pouches RESTORIS MCK Planning and Surgical Technique Guide Tibial Inlay Tibial Inlay Ultra high molecular weight polyethylene UHMWPE per ASTM F648 GUR 1050 resin type 2 Compression molded Radiographic Marker Titanium wire per ASTM F67 Machined from stock material Foil inner pouch Prior to sealing environmental oxygen air is purged with inert gas Impermeable preventing re entry of oxygen Tyvek Mylar outer pouch Tibial Onlay Onlay Insert Ultra high molecular weight polyethylene UHMWPE per ASTM F648 GUR 1050 resin type 2 Compression molded Onlay Baseplate Titanium alloy per ASTM F136 Onlay Insert Machined from stock material Onlay Baseplate Machined from stock material Locking surface satin finish Cement contacting surface
54. ly as needed for adequate visualization Undermine the subcutaneous tissues and place retractors to expose the lateral retinaculum Make a lateral parapatellar arthrotomy through the lateral retinaculum capsule and synovium The length of the incision and arthrotomy must be sufficient to enable proper patella retraction for femoral prosthesis insertion and to allow for tibial registration In certain circumstances exposure can be enhanced by lateralizing the arthrotomy 5 10 mm more lateral to the patella A T shaped cut in the arthrotomy can help to relax the soft tissues for improved visualization and easier retraction of the patella medially Inspect all compartments and evaluate the integrity of the Anterior Cruciate Ligament ACL and Posterior Cruciate Ligament PCL to confirm the indications for a unicondylar arthroplasty For an Onlay procedure elevate the lateral capsule from the proximal tibia until Gerdy s tubercle is released For an Inlay procedure this may not be required because less tibial exposure is needed A lateral collateral release should not be performed Debulk the fat pad as needed for exposure and resect the visible lateral meniscus Use caution interiorly to preserve the intermeniscal ligament and its attachment to the proximal tibia Release of this ligament can destabilize the medial meniscus Reflect patella medially to expose tibiofemoral joint space Trim any portions of loose or torn meniscus and
55. mplantation difficult External 3 0 C E 3 0 External 3 0 i Cen 1mm proud COE 1mm p r oud r2 Flexion 3 0 98 c All Implants All implants Lo Vial RESTORIS MCK Planning and Surgical Technique Guide Pre Operative Femoral Planning Verify Fit Select Lateral Femur Verify 1 2 Anterior tip of femoral component should not be proud of the cartilage map a cartilage point intra op if necessary Excessive anterior recess or proudness could cause patella tracking problems 99 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Lateral Unicondylar Implant Planning Intra Operative Sequence Verify the Pre Operative plan prior to Intra Operative planning Joint Balancing Pose Capture e Remove osteophytes and apply moment at ankle 5 10 Extension gap balancing 45 Mid flexion gap balancing 95 Flexion gap balancing 100 120 Maximum flexion Tibial Verify size and fit using same steps as Pre Op Planning Femoral Map cartilage at anterior tip Best match to Tibial tracking point Adjust placement to desired gap balancing graph profile Verify fit Joint Balancing Pose Capture e Prior to Joint Balancing Pose Capture Ensure osteophytes have been removed e During Joint Balancing Pose Capture Ensure VARUS moment is applied to tibia at each pose e Recommended Pose Captures for Joint Balanci
56. n models displayed on the Implant Planning software page represent the final locations of the implanted components However due to the interaction of the user with the stereotactic boundaries the actual resection may be slightly wider at the implant walls To prevent malalignment and to preserve bone always allow sufficient space between components and size appropriately Unicondylar Inlay Onlay Intra Operative Planning For details regarding the following steps refer to Appendix B for a step by step procedure to complete Medial Unicondylar Inlay Onlay Planning Appendix B describes the steps necessary to complete a Bicompartmental Inlay Onlay only the steps specific to a Medial Unicondylar procedure are relevant Refer to Appendix C for a step by step procedure to complete Lateral Unicondylar Inlay Onlay Planning Planning Sequence e Tibial Inlay Onlay e Femoral Condyle If the Tibial Inlay component is planned with less than a 2 mm rim of bone on the anterior posterior or medial sides the rim may be removed or fractured during resection 4 Adjustments to the plan from the nominal may be necessary to match specific patient anatomy RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 22 RESTORIS MCK Planning and Surgical Technique Guide Patellofemoral Intra Operative Planning For details regarding the following steps refer to Appendix B for a step by step procedure to
57. n should be selected in the drop down menu Figure 5C Then as long as the VISUAL button is enabled a visual of the surface of the trial will appear in the 3 D Figure 5A and 2 D Figure 5B views of Implant Planning These visuals represent the superior surface of the selected Implant thickness The CT views Implant Planning Graph Figure 5C and Tibial Tracking points will update accordingly when a new poly thickness is selected RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 12 RESTORIS MCK Planning and Surgical Technique Guide Figure 5A 3 D View of Poly Visual Figure 5B 2 D View of Poly Visual Poly Thickness 6 5 mm 3 Loose mm Angle degree m Figure 5C Implant Planning Graph with Poly Thickness Selection 13 RESTORIS MCK Planning and Surgical Technique Guide e Femoral Condyle Geometry The Femoral Condyle component is designed for use when load bearing Range of Motion ROM is expected to be up to 155 degrees The Femoral Condyle component has a patella relief feature on the anterior tip so as not to impinge with the patella or the Patella component during high flexion ROM The visual of the Femoral Condyle contains a high point groove Figure 6 through the model that marks a reference for the potential tibial tracking pathway During Intra Op planning the groove can be used to align the Femoral Condyle to the tracking points collected during Joint Bala
58. ncing Pose Capture Figure 6 Femoral Condyle Visual 14 RESTORIS MCK Planning and Surgical Technique Guide Unicondylar Inlay Onlay Pre Operative Planning For details regarding the following steps refer to Appendix A for a step by step procedure to complete Medial Unicondylar Inlay Onlay Planning Appendix A describes the steps necessary to complete a Bicompartmental Inlay Onlay only the steps specific to a Medial Unicondylar procedure are relevant Refer to Appendix C for a step by step procedure to complete Lateral Unicondylar Inlay Onlay Planning Planning Sequence e Tibial Inlay Onlay e Femoral Condyle If the Tibial Inlay component is planned with less than a 2 mm rim of bone on the A anterior posterior or medial sides the rim may be removed or fractured during resection F Patellofemoral Pre Operative Planning Adjustments to the plan from the nominal may be necessary to match specific patient anatomy For details regarding the following steps refer to Appendix A for a step by step procedure to complete Patellofemoral Planning Appendix A describes the steps necessary to complete a Bicompartmental Inlay Onlay only the steps specific to a Patellofemoral procedure are relevant Planning Sequence e Patellofemoral Trochlear as it will decrease the lateral patella jump height and increase the risk of lateral patella subluxation 1 External rotation of the Patellofemoral Trochlear compone
59. ng Remove Patellofemoral Trochlear Trial by screwing the Slaphammer into the threaded hole and extracting the assembly Use pulsed lavage or similar technique to remove fatty deposits from the cancellous porous structure and pat dry Apply cement to the Patellofemoral Trochlear Implant ensuring that cement fully covers the back side of the implant including the distal tongue Apply cement to the resected cavity and firmly pack the cement into the bone using your fingers Place the Patellofemoral Trochlear Implant onto the femur and impact with the Patellofemoral Impactor Confirm that the implant is fully seated Carefully remove all excess extruded cement 10 Hold knee joint stationary until cement has cured 41 Planning and Surgical Technique Guide If the MAKO Patella Resection instruments are used follow the instructions below If an alternate method of a patella resection is employed begin at the Patella Sizing Drill Guide instructions starting at Figure 25 and continue to the end of the procedure Place the leg in full extension to expose the patella and to release tension on the quadriceps Measure the maximum patella thickness using the Patella Calipers degree of accuracy 0 5 mm Figure 20 Estimate patella implant size by measuring the superior inferior height of the patella articular surface To determine proper re section thickness refer to the table below all dimensio
60. ng 5 10 Extension gap balancing 45 Mid flexion gap balancing 95 Flexion gap balancing 100 120 Maximum flexion 100 RESTORIS MCK Planning and Surgical Technique Guide RESTORIS MCK Tibial Component Intra Operative Planning Overview 3 mm proud of bone note for the Inlay do not inset more than 3 5 mm below cortical bone surface Onlay maximize cortical coverage without overhanging Slightly internally rotated with respect to tibial Inlay maintain offset of 2 3 eminence ridge mm from cortical rim N Medial edge does not Onlay best match baseplate intrude into tibial perimeter with cortical rim eminence Inlay best match inlay perimeter to 2 3 mm cortical rim offset RESTORIS MCK Femoral Component Intra Operative Planning Overview Set Femoral anterior tip just proud of bone slightly inset to cartilage Size Femoral by aligning to meniscal notch ins Best match Femoral lateral edge to i Best match Femoral High Point Groove to Tibial trace Bonis on condylar curvature inset from Pas Ba Mni da Joint Balancing Pose Capture lateral edge 1 mm d 0 1 5 mm looseness RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 101 Planning and Surgical Technique Guide Tibial Component Lateral Unicondylar Intra Operative Tibial Planning Verify Size Select Lateral Tibia Primary Verify Tibial size Onlay Idea
61. nlay An artificial gap is included in the Tibial Onlay component visual see Figure 4 This gap does not alter the articular surface of the Insert or any of the geometry of the Baseplate The bottom of the gap is the actual superior surface of the Baseplate Implant or Trial The gap allows the user to distinguish the superior Baseplate surface from the inferior Insert surface during planning and to verify placement in CT View Figure 4 Tibial Onlay Visual 11 RESTORIS MCK Planning and Surgical Technique Guide Tibial Inlay To assist in Implant Planning a reference groove is included in the Tibial Inlay visual side wall perimeter Figure 5 The center of the groove is 3 5 mm from the bottom of the implant and the top of the cement channel is 2 5 mm from the bottom of the implant Per Appendix A B and C the Inlay should not be inset more than 3 5 mm below cortical bone surface Groove Cement Channel Figure 5 RESTORIS MCK Inlay Visualization Polymer Thickness Options As outlined in the MAKOplasty Partial Knee Application User Guide PN 206388 15 the available thicker poly options Inlay 7 5 mm and 8 5 mm and Onlay 9 0 mm and 10 0 mm can be selected in the cases post resection where a thicker insert must be used Always plan and resect using the thinnest poly This feature is intended ONLY for analysis during trialing When a thicker polyethylene trial is used in the joint the corresponding thickness optio
62. nning Adjust AP so that PF is split midway by mapped surface Internal uU Pomona co E LP Flexion 5 0 85 Planning and Surgical Technique Guide Intra Operative Patellofemoral Planning Select PF Verify 2 Set the crosshair at the proximal implant in the Sagittal view Adjust F E of Trochlear component to best match x 1 mm the 3 most anterior trochlear groove points NOTE if the mapped points lie on arthritic bone and not cartilage adjust F E to be 2 mm proud of bone surface Verify ACL notch PF distal tip should be anterior to Blumensaat s line 0 5 0 Flexion Select PF Primary TRANSVERSE Adjust V V and SI to best match patellar transition zones to mapped lateral cartilage If lateral cartilage is thicker than medial cartilage match lateral cartilage If medial cartilage is e erm thicker than lateral C AE cartilage match PF to be M halfway between medial and lateral cartilage TAV Size 4 Implant View PF Primary Proud 1 4 mm Flexion 4 5 Internal S 2 0 Operative Side left Valgus Implant Planning 0 0 86 RESTORIS MCK Planning and Surgical Technique Guide Intra Operative Patellofemoral Planning Select PF Verify 1 Verify that the PF rests on or in mapped surface If the mapped surface is inside the PF no action is required If PF does not contact mapped surface translate pos
63. ns are in mm Figure 20 Saw Guide Assemble the appropriately sized Saw Guide into the Patella Clamp to create a Saw Guide Assembly as shown in Figure 21 Figure 21 42 RESTORIS MCK Planning and Surgical Technique Guide Align the Saw Guide cutting slot to the medial side of the patella Position the handle approximately parallel to the tibia Figure 22 Engage the Saw Guide teeth onto the center of the patellar articular surface ridge and allow the wings to guide orientation onto the medial and lateral patella facets Close the Saw Guide Assembly around the patella Apply a slight clamping force ensuring that the patellar transition zones and Saw Guide teeth provide proper alignment and that the cutting slot is comfortably accessible to the surgeon s Figure 22 dominant hand and the saw The anterior side of the patella should be centered in the Clamp Jaw Use the Anterior Cut Reference Guide to verify that the start and exit of the saw blade resection is where desired Figure 23 The proper planar resection is made when the cutting slot is aligned with the quadriceps mechanism attachments and with the medial and lateral cartilage bone demarcations Figure 23 For Saw Guides without wings engage the teeth onto the center of the patella articular surface ridge and apply a slight clamping force 43 RESTORIS MCK Planning and Surgical Technique Guide Turn the knob tensioner on the Clamp to ap
64. nt is not recommended Do not put the Patellofemoral Trochlear component in more than 2 valgus as this will align the trochlear groove away from the anatomic axis of the femur and increase the risk of lateral patella subluxation Adjustments to the plan from the nominal may be necessary to match specific patient RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand anatomy 15 RESTORIS MCK Planning and Surgical Technique Guide Bicompartmental Pre Operative Planning For details regarding the following steps refer to Appendix A for a step by step procedure to complete Bicompartmental Planning Planning Sequence e Tibial Inlay Onlay e Bicompartmental Patellofemoral Medial Femoral Condyle Patellofemoral Trochlear Femoral Condyle If the tibial Inlay component is planned with less than a 2 mm rim of bone on the anterior posterior or medial sides the rim may be removed or fractured during resection External rotation of the Patellofemoral Trochlear component is not recommended as it will decrease the lateral patella jump height and increase the risk of lateral patella subluxation Do not put the Patellofemoral Trochlear component in more than 2 valgus as this will align the trochlear groove away from the anatomic axis of the femur and increase the risk of lateral patella subluxation Adjustments to the plan from the nominal may be necessary to match specific patient ana
65. omponent into a rough AP and ML position Drag component to 3 mm proud Onlay Visual gap Gap created to distinguish between Baseplate amp Insert Note gap created by removing material from Insert so Baseplate shown corresponds to actual geometry 58 Pre Operative Tibial Planning Size Determine Tibial Component size Onlay Ideal size is largest component that will not overhang AP ML and not intrude into tibial intercondylar eminence Inlay Ideal size is largest component that is 2 3 mm from cortical rim and not intrude into tibial intercondylar eminence Tibial Onlay 5 internal 5 external AP on cortical rim 0 varus lt 1 5 varus ML on cortical rim 3 slope 7 slope SI 2 5 3 5 mm proud Tibial Inlay 5 internal lt 5 external AP 2 3 mm from cortical rim 1 varus 3 varus ML 2 3 mm from cortical rim 3 slope 7 slope SI 2 5 3 5 mm proud Planning and Surgical Technique Guide All Implants Display Axes RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 59 Planning and Surgical Technique Guide Pre Operative Tibial Planning Fit Adjust posterior slope to be slightly less than patient tibial bone slope Removal of meniscus and excessive slope can stress the ACL Adjust proudness to 3 mm Adjust AP position Onlay avoid overhang Inlay 2 3 mm inset from cortical rim Adjust V V Onlay st
66. oval or if axial rotation is outside the axial rotation delta window It is recommended that the trial or implant insert thickness used during joint gap evaluation be the same as the poly thickness selected in the drop down menu If they are not errors in the values may result If the trial or implant insert thickness is changed it is recommended that you delete the captured gap poses and recapture new contact and gap poses 83 Planning and Surgical Technique Guide Patellofemoral Component Intra Operative Patellofemoral Planning Select PF Primary Map Cartilage Bone Map 2 bone points on the proximal edge near the medial and lateral violet tip points Edge points will ensure that the implantis placed midway through bone surface Map Cartilage Bone Map 5 cartilage points along the deepest point of the trochlear groove most anterior to most distal Internal 0 0 I Extension T F 84 Planning and Surgical Technique Guide Intra Operative Patellofemoral Planning Map Cartilage Bone Map a minimum of 3 cartilage points on each of the lateral and medial PF patellar transition zone edges Selecting edge points next to the 2 violet points and 1 edge point in between will provide ideal spacing Interna 4 8 NOTE These 13 are the minimum recommended points to be mapped more points can be collected as needed to ensure a successful implant plan i Fi img lant Pla
67. planning 71 Joint Balancing Pose Capture Remove osteophytes and apply moment at ankle 5 10 Extension gap balancing 45 Mid flexion gap balancing 95 Flexion gap balancing 100 120 Maximum flexion Tibial Verify size and fit using same steps as Pre Operative Planning Patellofemoral Trochlear Map bone and cartilage Adjust placement and best match proximal lateral tip trochlear groove and patella transition Verify fit Femoral Map cartilage at anterior tip Best match to Tibial tracking point Adjust placement to desired gap balancing graph profile Verify fit RESTORIS MCK Planning and Surgical Technique Guide Intra Operative Planning Joint Balancing Pose Capture Prior to Joint Balancing Pose Capture Ensure osteophytes have been removed During Joint Balancing Pose Capture Ensure VALGUS moment is applied to tibia at each pose e Recommended Pose Captures for Joint Balancing 5 10 Extension gap balancing 45 Mid flexion gap balancing 90 Flexion gap balancing 100 120 Maximum flexion Joint balancing not required for RESTORIS MCK PFJ procedure because the tibia is not registered Intra Operative Joint Balancing Pose Capture Obtain pose captures for joint balancing at approximately 5 10 knee flexion Extension gap balancing 12 Planning and Surgical Technique Guide Intra Operative Joint Balancing Pose Capture
68. ply a clamping force on the patella Place thumb or finger on knob tensioner to prevent possible unwinding during resection Insert a 25 mm x 1 27 mm 050 saw blade through the Saw Guide and resect the articular surface of the patella Figure 24 Ensure that the resection is flat and smooth Unscrew the knob tensioner and remove the Saw Guide Assembly from the patella Figure 24 Using the Patella Sizing Drill Guides select the appropriate size Patella Implant 26 29 32 35 38 or 41 mm diameter The optimal patella size is the largest size that does not overhang the bone superior inferiorly Assemble the Patella Sizing Drill Guide into the Drill Guide Handle to create a Drill Guide Assembly such that the selected patella size is opposite the handle teeth Figure 25 In the example shown the selected 38 mm size is opposite the handle teeth and the 41 mm size is assembled to the Drill Guide Handle Figure 25 44 RESTORIS MCK Planning and Surgical Technique Guide Clamp the Drill Guide Assembly firmly onto the patella so that the spikes fully engage and the drill guide sits flat on the bone surface For proper patella tracking the Patella Sizing Drill Guide should be aligned with the former patella ridge i e medialized on the patella bone This will lateralize the remaining patella bone Centering the Patella Sizing Drill Guide will medialize the remaining patella bone which can tighten the lateral
69. presence of infection including history of infection acute or chronic local or systemic must be considered e Insufficient bone quality may affect the stability of the implant e Patient size may complicate the resection procedure Body Mass Index should be considered e Loss of ligament structures may prevent creation of an ideal intra operative plan e The significance of the deformity Hyperextension Flexion Contracture or Varus Valgus must be considered e Patients with inflammatory arthritis or tricompartmental disease are not candidates for the procedure RESTORIS MCK Planning and Surgical Technique Guide WARNINGS AND PRECAUTIONS Familiarity with and attention to appropriate surgical technique for unicondylar patellofemoral multicompartmental arthroplasty and RESTORIS MCK is essential for success of the procedure Only surgeons who have reviewed the literature regarding unicondylar and multicompartmental knee replacement and have had training in the technique using RIO should perform this procedure The surgeon or his designee should instruct patients in the limitations of multicompartmental knee replacement and these patients should be taught to govern their activities accordingly Implants and trial components from different manufacturers or implant systems should never be used together since articular and dimensional compatibility cannot be assured The use of the RESTORIS MCK Implant system in any configuration req
70. release soft tissue from the anterior surface of the tibia as needed for improved exposure and registration Patellofemoral Incision and Exposure 1 With the knee flexed at about 45 create a skin incision directly over the median plane of the knee The underlying arthrotomy will be placed more medially than the skin incision to prevent wound complications As a guide for a minimally invasive technique the incision should extend from the superior border of the patella to the top of the tibial plateau Extend the incision proximally or distally as needed for adequate visualization RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 18 6 RESTORIS MCK Planning and Surgical Technique Guide Undermine the subcutaneous tissues and place retractors to expose the medial retinaculum Make a medial sub vastus or mid vastus arthrotomy through the medial retinaculum capsule and synovium The length of the incision and arthrotomy must be sufficient to enable proper patella retraction for trochlear prosthesis insertion and femoral registration Inspect all compartments and evaluate the integrity of the Anterior Cruciate Ligament ACL and Posterior Cruciate Ligament PCL to confirm the indications for a patellofemoral arthroplasty Debulk the fat pad as needed for exposure and elevate any suprapatellar synovium for trochlear exposure Reflect patella laterally to expose patellofemoral joint space
71. rgest component that is 2 3 mm from cortical rim and not intrude into tibial intercondylar eminence Options Screen Help Tibial Onlay 10 internal 5 external AP on cortical rim 0 valgus 1 5 valgus ML on cortical rim 0 slope 7 slope SI 2 5 3 5 mm proud Size Select Proud Tibial Inlay 10 internal e 5 external AP 2 3 mm from cortical rim 1 valgus 3 valgus ML 2 3 mm from cortical rim 0 slope 7 slope SI 2 5 3 5 mm proud All Implants RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 93 Planning and Surgical Technique Guide Pre Operative Tibial Planning Fit Adjust posterior slope to be slightly less than patient tibial bone slope Removal of meniscus and excessive slope can stress the ACL Adjust proudness to 3 mm Adjust AP position Onlay avoid overhang External Inlay 2 3 mm inset from da cortical rim Adjust V V Onlay stay within positioning limits Inlay adjust to be slightly less than tibial valgus slope Adjust ML to avoid intrusion into the tibial eminence and Onlay avoid overhang Inlay 2 3 mm inset from cortical rim Pre Operative Tibial Planning Fit Rotate so edge of component is slightly internally rotated with tibial intercondylar eminence edge and to avoid PCL notch Note ignore anterior bone when assessing I E rotation Internal 0 9 Gwin Poste
72. rior Slope 4 0 RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 94 Planning and Surgical Technique Guide Pre Operative Tibial Planning Verify Fit Select Lateral Tibia Verify 1 Re adjust proudness to 3 mm if necessary Onlay Verify implant rests on cortical rim and does not interfere with eminence Inlay Verify implant is 2 3 mm from cortical rim not including osteophytes To maintain subchondral bone plate do not inset 23 5 mm below cortical surface Note some bone might be proud at anterior tip Select Lateral Tibia Verify 2 Onlay Verify implant does not overhang AP amp ML Scroll through slices as necessary to ensure proper fit Inlay Verify implant is 2 3 mm from cortical rim not including osteophytes Scroll through slices as necessary to ensure proper fit Internal Select Proud All Implants EU e Posterior Slope X i 4 0 Select Proud Visual es Posterior Slope 4 0 RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 95 Planning and Surgical Technique Guide Femoral Component Lateral Unicondylar Pre Operative Femoral Planning Default Position Select Lateral Femur Primary Crosshair automatically positioned at flexion facet center near posterior peg tip 73 3D view set to Transverse Distal Component is imported in Internal Defaul
73. rt the Femoral Condyle With applicable Tibial Trial in place move the knee through a full range of motion Remove Femoral Trial by screwing the Slaphammer into the threaded hole and extracting the assembly Use pulsed lavage or similar technique to remove fatty deposits from the cancellous porous structure and pat dry Apply cement to the Femoral Condyle For proper fixation ensure cement is applied to the posterior face of the Femoral Condyle Apply cement to the distal resected cavity and firmly pack the cement into the bone using your fingers Place the Femoral Condyle onto the femur and impact with the Femoral Impactor Confirm that the implant is fully seated Carefully remove all excess extruded cement With the Femoral Condyle centrally loading the Tibial component hold the knee joint stationary until cement has cured 33 RESTORIS MCK Planning and Surgical Technique Guide Tibial Onlay To facilitate component insertion it may help to insert the Femoral Condyle component prior to the Tibial component 1 Insert the selected size Tibial Baseplate Trial impact as applicable and Insert Trial Figure A Correct assembly of the Tibial Figure B Proper impaction technique when Baseplate Inlay Impactor Ensure that the using the Tibial Baseplate Inlay Impactor Impactor Head is completely snapped onto the Impactor Handle before use 2 With the applicable Femoral Trial in place move the knee through a ful
74. s valgus The Contact values are the angles recorded during Capture Contact The Varus or Valgus value is the live varus valgus angle of the knee in the current pose When Pre Resection is toggled on and the knee is within 5 flexion of the pre resection pose the Pre resection value recorded during Joint Balancing is displayed The live varus valgus angle should only be compared to the Pre resection angle when the same varus valgus moment is applied to the knee as during pre resection Joint Balancing Internal External Rotation The coronal kinematic window displays the relative difference delta of the current internal external rotation axial rotation to that taken during the contact pose When Pre Resection is toggled on and the knee is within 5 flexion of the pre resection pose a blue dot will appear on the delta axial rotation dial indicating the axial rotation difference between the contact pose and pre resection pose For best comparison to pre resection values the blue dot should be within the delta window Capture Gap The Gap value is the joint space between the Femoral and Tibial components This value should read zero when no moment is applied to the leg To view the joint gap value at any flexion angle apply the same varus valgus moment that was applied during Joint Balancing Visually confirm that the actual gap seen matches that displayed in the gap value box When Pre Resection is toggled on and the knee is
75. se of any particular product before using it in surgery The information presented is intended to demonstrate the breadth of Stryker product offerings A surgeon must always refer to the package insert product label and or instructions for use before using any Stryker product Products may not be available in all markets because product availability is subject to the regulatory and or medical practices in individual markets Please contact your Stryker representative if you have questions about the availability of Stryker products in your area Stryker Corporation or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks Stryker Mako All other trademarks are trademarks of their respective owners or holders JN MAKO e ec r RMS UK Ltd 28 Trinity Road SURGICAL Come Restoring Quality of Life Through Innovation Nailsea Somerset UK BS48 4NU MAKO Surgical Corp C 0086 2555 Davie Road Fort Lauderdale FL 33317 1 866 647 6256 makosurgical com MAKO Surgical Corp 206591 15 r00 12 14 ud
76. t t This feature does not replace the need for cartilage mapping Mid Flexion and Femoral Condyle Rotation When Mid Flexion is checked in the Gap Settings the Femoral Condyle component flexion rotation angle will be adjusted to best match the desired mid flexion gap setting while staying within the recommended positioning limits 5 extension to 5 flexion rotation If the user prefers a different flexion rotation angle or one outside the recommended positioning limits then Mid Flexion can be unchecked and Quick Fit will only translate the Femoral Condyle component to meet the desired extension and flexion gap settings Quick Fit provides a quick and easy suggested position of the Femoral Condyle component based on the inputs of the surgeon poses and gap settings for a given Tibial component plan The surgeon should fully consider all gap values for all poses even if certain poses are not used by Quick Fit For example if the target flexion pose angle is 90 and poses were taken at 93 and 115 flexion only the pose at 93 will be used by Quick Fit but the gap value at 115 should be considered before accepting the final plan Final acceptance of the implant plan must still be made by the surgeon 80 RESTORIS MCK Planning and Surgical Technique Guide Quick Fit does not adjust Femoral Condyle medial lateral translation varus valgus rotation and internal external rotation Therefore the surgeon still must manually ad
77. t location i Size 5 is Default size All Implants Flexion 0 0 Drag and drop component into a rough position on the lateral condyle Drag component to 1 mm proud Internal 0 0 All Implants RP C Flexion 0 0 96 Planning and Surgical Technique Guide Pre Operative Femoral Planning Size Meniscal Notch Determine femoral component size Ideal size is when anterior tip is approximately aligned with meniscal notch in 3D view and best matches femoral J curve Femoral Condyle 5 internal 5 external AP 1 mm proud of bone 3 varus lt gt 3 valgus ML centered on condyle 5 flexion 5 extension Sl 1 mm proud of bone Internal 0 0 M M9 TE h Ceim Flexion 0 0 97 Planning and Surgical Technique Guide Pre Operative Femoral Planning Fit Match lateral condylar curvature of bone Adjust I E to match condylar curvature excluding osteophytes Adjust ML to centralize condyle and to be almost 1 mm inset from lateral edge Adjust V V if necessary Do not try to match component shape with arthritic bone shape using V V Note Some valgus may be necessary to follow posterior condylar curvature Match J curve Adjust AP SI amp F E to match bone J curve and to be 1 mm proud of bone Adjust F E as necessary to ensure anterior tip is slightly inset into bone Excessive flexion will make i
78. t the template is fully seated on the tibia Drill peg holes for the Tibial Baseplate using the Patellar Tibial Peg Drill Figure 13 Remove Baseplate Template from the tibia Patellofemoral Template Affix the Patellofemoral Template to the resected bone pocket using the Headed Bone Pins and the Pin Pusher Figure 14 Figure 14 30 RESTORIS MCK Planning and Surgical Technique Guide Drill the peg holes for the Patellofemoral Trochlear Implant using the Femoral Peg Drill Figure 15 Figure 15 Remove the Headed Bone Pins using the Pin Puller and remove the Patellofemoral Template Figure 16 Figure 16 31 RESTORIS MCK Planning and Surgical Technique Guide TRIAL REDUCTION AND IMPLANTATION The steps in this section are guidelines and do not constitute a complete surgical technique PpPPPP Care should be used in the handling of the implant components to minimize damage to the component surfaces The surgeon should use care to ensure complete cement support on all parts of the prosthesis contacting resected bone It is important to pressurize cement into both tibial and femoral peg holes Implants must not be reused The surgeon must not allow damage to polished bearing surfaces because this may accelerate wear of the implant components Any alteration or damage to an implant component may result in failure under load Any prostheses so damaged must not be used Care should be used when insertin
79. terior until PF contacts mapped surface Note Moving the PF in this view will change the fit in the previous step 87 Planning and Surgical Technique Guide Femoral Component Intra Operative Femoral Planning Verify Size Select Medial Femur Primary Verify intercomponent gap 23 mm and Femoral has full posterior condyle coverage Map cartilage points in transition region to ensure smooth patella handoff Adjust I E and or ML to align Femoral High Point Groove to Tibial tracking points as best as possible This will aid in central Tibial component The Femoral High Point Groove is the probable tibial tracking pathway For better visualization set Implant View to Tibia Primary and turn on All Implants to cycle through the flexion angles and watch the actual tracking of the femoral component on the tibia component TRANS VERSE Geis Internal 2 0 CORON AL t P Extension 0 0 Fi Internal 2 0 Varus Extension FS 88 Nn Sel on amp towen Hey TAT RESTORIS MCK Medial Bi Comp Onlay Size 2 dl Implant Wies Lateral Fenur Primary ESTEE ETT E fs exin a s Guek Er m Cha Fesrrasar uca Pontia fisa 5aMWis ana peral hke Side lefi Loose 1 9rnm Tip distance 1 3mm imamPamio RESTORIS MCK Medial Bi Comp Onlay 2 m LIII ie Lateral Feur Primam 7 Popes TA ii Ea maw
80. tomy A A A RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 16 RESTORIS MCK Planning and Surgical Technique Guide BONE PIN PLACEMENT For additional information regarding bone pin placement see the MAKOplasty Partial Knee Application User Guide PN 206388 15 be more proximally placed to accommodate Patellofemoral Trochlear and Patella preparation a For Patellofemoral or Bicompartmental procedures femoral bone pins might need to INCISION AND EXPOSURE Medial Incision and Exposure 1 With the knee flexed at about 45 create a skin incision directly over the median plane of the knee The underlying arthrotomy will be placed more medially than the skin incision to prevent wound complications As a guide for a minimally invasive technique the incision should extend from the inferior border of the patella to approximately 2 cm below the tibial plateau Extend the incision proximally or distally as needed for adequate visualization Undermine the subcutaneous tissues and place retractors to expose the medial retinaculum Make a medial parapatellar arthrotomy through the medial retinaculum capsule and synovium If necessary extend the arthrotomy proximally by making a medial snip of the Vastus Medialis Oblique VMO at the distal insertion site of the patella this will aid in exposure and help mobilize the patella The length of the incision and arthrotomy must be sufficient
81. uires the use of the Robotic Arm Interactive Orthopedic System RIO For more details on RIO driven implementation see the RIO System User Guide PN 203857 15 and MAKOplasty Partial Knee Application User Guide PN 206388 15 RESTORIS MCK is not for lateral bicompartmental patellofemorotibial replacement j or for tricompartmental knee replacement Adverse Effects As with any knee system potential adverse effects include infection loosening of the components breakage or bending of the components or change in position of the components There have been reports of sensitivity reactions to the components of knee replacement systems Other potential adverse effects of knee surgery include neurovascular damage dislocation thromboembolic disease and other less common adverse effects Implant Packaging Sterilization If any seals or packages are breached then the component should not be used A minimum of 2 5 megarads of gamma irradiation is used for all RESTORIS MCK components The UHMWPE components are subjected to gamma sterilization and packaged in an inert gas environment RESTORIS MCK Planning and Surgical Technique Guide IMPLEMENTATION USING RIO RESTORIS MCK Procedure Options 1 RESTORIS MCK Uni Inlay Medial or Lateral e Femoral Condyle e Tibial Inlay 2 RESTORIS MCK Uni Onlay Medial or Lateral e Femoral Condyle e Tibial Baseplate e Tibial Onlay Insert 3 RESTORIS MCK PF e Patellofemoral Trochlear component e Pat
82. ure 1 RESTORIS MCK Configuration RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 3 RESTORIS MCK Planning and Surgical Technique Guide INDICATIONS FOR USE RESTORIS MCK Uni RESTORIS MCK Uni components are for use in unicompartmental knee arthroplasty as a result of moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis revision of previous unsuccessful unicompartmental knee replacement or as an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis These components are single use only and are intended for implantation with bone cement previous unsuccessful unicompartmental knee replacement is not approved in the EU RESTORIS MCK PF RESTORIS MCK PF is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella patients with a history of patellar dislocation or patella fracture or patients with failed previous surgery arthroscopy tibial tubercle elevation lateral release where pain deformity or dysfunction persists These components are single use only and are intended for implantation with bone cement RESTORIS MCK Bicompartmental RESTORIS MCK Bicompartmental is indicated for single or multicompartmental knee replacement used in conjunction with the RIO Robotic Arm Interactive Orthopedic System in individuals with osteoarthritis or post tr
83. us and flexion extension degree references are made with respect to respect to the AP axis of the applicable bone General Design Considerations for Implant Planning e Material CoCr and UHMWPE are the industry standard for component articulation Titanium was chosen for the baseplate because of its high strength and fatigue resistance All UHMWPE components are conventional compression molded polyethylene They are gamma sterilized in an inert environment e Fixation All metallic implant pegs have a 6 5 mm diameter designed to have a slight press fit with a prepared peg hole when cemented The Tibial Inlay has an outer cement channel for high fixation strength e Compatibility All Femoral Condyle component sizes are compatible with all Tibial Inlay or Onlay component sizes full size compatibility All Patellofemoral Trochlear component sizes are compatible with all Patella component sizes full size compatibility Component sizing for the Bicompartmental Femoral Condyle is limited to one size larger and one size smaller 1 up 1 down than the selected Patellofemoral Trochlear component This aids in proper patella transitioning RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand RESTORIS MCK Planning and Surgical Technique Guide e Bicompartmental Geometry The Femoral Condyle and Patellofemoral Trochlear components were designed from a single continuous femur art
84. y perimeter to 2 3 mm cortical rim offset RESTORIS MCK Femoral Component Pre Operative Summary Set Femoral anterior tip just Size Femoral by aligning to proud of bone slightly inset to meniscal notch cartilage Best match Femoral lateral edge to condylar curvature inset from lateral edge 1 mm Best match sagittal J curve Centralize component on condyle offset from bone 1 mm RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand 91 Planning and Surgical Technique Guide Tibial Component Lateral Unicondylar Pre Operative Tibial Planning Default Position Component is imported in Default location Size 5 is Default size Select Lateral Tibia Primary A i i Crosshair automatically positioned at implant center 3 5 mm from top Center of medial peg ML midplane gt 3D view set to Transverse Proximal Drag and drop component into a rough AP and ML position Drag component to 3 mm proud Onlay visual gap Gap created to distinguish between Baseplate amp Insert Note gap created by removing material from Insert so Baseplate shown corresponds to actual geometry 92 Planning and Surgical Technique Guide Pre Operative Tibial Planning Size Determine Tibial Component size Onlay Ideal size is largest component that will not overhang AP ML and not intrude into tibial intercondylar eminence Inlay Ideal size is la

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