RESTORIS® MCK MultiCompartmental Knee System

Technical Data SheetRESTORIS ® MCKMultiCompartmental Knee SystemInnovative and enabling, specifically designed for the precision of RIO ®– bringing new capability and more treatment options.ACL and PCL Sparing Alternative to TKA• Designed for better kinematics• Retained proprioception• Promotes rapid recoveryModularity Replaces Only the Diseased Compartments• Unicondylar, Patellofemoral, and Bicompartmental options• Removes significantly less bone, preserving bone stockContoured Surfaces• Implant shapes designed from analysis of over 100 knee CT scans• Anatomic sculpted resection enabled by RIO ® Robotic Arm Interactive Orthopedic SystemPatient Specific Fit• Six standard implant sizes provide a modular customized fit• Components positioned to patient specific anatomy for optimal patella tracking andpatella transitioningIntra-operative Flexibility• Tibial-femoral full size compatibility• Patellofemoral-patella full size compatibility• Patellofemoral-femoral 1 up / 1 down compatibilityFor domestic distribution only.

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemIndications for use 1• 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– As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritisThese components are single use only and are intended for implantation with bone cement.• RESTORIS ® MCK - PF is intended to be used in cemented patellofemoral arthroplasty in patients with degenerativearthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patientswith failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunctionpersists. These components are single use only and are intended for implantation with bone cement.• RESTORIS ® MCK is indicated for single or multicompartmental knee replacement used in conjunction with RIO ® theRobotic Arm Interactive Orthopedic System 2 , in individuals with osteoarthritis or post-traumatic arthritis of the medialtibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:– Medial unicondylar– Lateral unicondylar– Patellofemoral– Medial bicompartmental (medial unicondylar and patellofemoral)RESTORIS ® MCK is for single use only and is intended for implantation with bone cement.1. Indications for use stated in letter from FDA to MAKO Surgical. Reference K082172 and K090763.2. MAKO robotic arm system software supports only medial unicondylar, lateral unicondylar, patellofemoral and medial bicompartmental reconstruction.

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemMaterialPatellofemoral /FemoralCobalt chromium (CoCr)alloy per ASTM F75Tibial Inlay Tibial Onlay Patella DomeTibial Inlay:Ultra-high molecular-weightpolyethylene (UHMWPE) perASTM F648- GUR 1050, resin type 2- Compression moldedOnlay Insert:Ultra-high molecular weightpolyethylene (UHMWPE) perASTM F648- GUR 1050, resin type 2- Compression moldedUltra-high molecular-weightpolyethylene (UHMWPE) perASTM F648- GUR 1050, resin type 2- Compression moldedRadiographic Marker:Titanium wire per ASTMF67Onlay Baseplate:Titanium alloy per ASTMF136ManufacturingProcessCast, heat-treated- Articular surface:polished- Cement-contactingsurface: grit blastedMachined from stockmaterialOnlay Insert:Machined from stockmaterialOnlay Baseplate:Machined from stockmaterial- Locking surface: satinfinish- Cement-contactingsurface: grit blastedMachined from stockmaterialPackagingTyvek/Mylar inner andouter pouchesFoil inner pouch- Prior to sealing,environmental oxygen(air) is purged with inertgas- Impermeable, preventingre-entry of oxygenTyvek/Mylar outer pouchOnlay insert:Foil inner pouch- Prior to sealing,environmental oxygen(air) is purged with inertgas- Impermeable, preventingre-entry of oxygenTyvek/Mylar outer pouchOnlay baseplate:Tyvek/Mylar inner and outerpouchesFoil inner pouch- Prior to sealing,environmental oxygen(air) is purged with inertgas- Impermeable, preventingre-entry of oxygenTyvek/Mylar outer pouchSterilizationGamma, 2.5 – 4.0 MradShelf Life5 yearsThe third-party trademarks used herein are trademarks of their respective owners.

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemFemoral CondyleSizeAP (mm)ML(mm)CondylarHeight(mm)DistalThickness(mm)PosteriorThickness(mm)Peg 1Height(mm)Peg 2Height(mm)Peg Diameter(mm)Keel Height(mm)1* 42.0 16.0 30.9 4.0 5.8 9.00 11.0 6.5 0.02 45.0 17.0 33.1 4.0 6.0 9.75 12.0 6.5 0.03 48.0 18.0 35.4 4.0 6.2 10.50 13.0 6.5 0.54 51.0 19.0 37.6 4.0 6.4 11.25 14.0 6.5 1.05 54.0 20.0 39.9 4.0 6.6 12.00 15.0 6.5 1.56 57.0 21.0 42.1 4.0 6.8 12.75 16.0 6.5 2.07 60.0 22.0 44.4 4.0 7.0 13.50 17.0 6.5 2.58* 63.0 23.0 46.6 4.0 7.2 14.25 18.0 6.5 3.0*Size 1 and 8 are not standard sizes, but are available as special order.MLPosterior ThicknessPeg DiameterPeg 2 HeightCondylar HeightPeg 1 HeightAP

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemTibial InlaySize AP (mm) ML (mm) Thickness (mm)1* 30.0 17.5 6.5 7.5 8.52 33.0 19.0 6.5 7.5 8.53 36.0 20.5 6.5 7.5 8.54 39.0 22.0 6.5 7.5 8.55 42.0 23.5 6.5 7.5 8.56 45.0 25.0 6.5 7.5 8.57 48.0 26.5 6.5 7.5 8.58* 51.0 28.0 6.5 7.5 8.5*Size 1 and 8 are not standard sizes, but are available as special order.APMLThickness

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemTibial OnlaySizeBaseplate AP(mm)Insert AP(mm)Baseplate /Insert ML(mm)PegHeight(mm)PegDiameter(mm)PegAngle(mm)KeelHeight(mm)Thickness (mm)1* 38.0 34.8 21.5 7.0 6.5 30 5.0 8.0 9.0 10.02 41.0 37.5 23.0 7.0 6.5 30 5.0 8.0 9.0 10.03 44.0 40.3 24.5 7.0 6.5 30 5.0 8.0 9.0 10.04 47.0 43.0 26.0 7.0 6.5 30 5.0 8.0 9.0 10.05 50.0 45.8 27.5 8.0 6.5 30 6.0 8.0 9.0 10.06 53.0 48.5 29.0 8.0 6.5 30 6.0 8.0 9.0 10.07 56.0 51.3 30.5 8.0 6.5 30 6.0 8.0 9.0 10.08* 59.0 54.0 32.0 8.0 6.5 30 6.0 8.0 9.0 10.0*Size 1 and 8 are not standard sizes, but are available as special order.Insert APBaseplateInsertMLBaseplateAPThicknessPeg HeightPeg AngleKeel HeightPeg Diameter

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemPatellofemoralSize Height (mm) Width (mm)Peg 1 Height(mm)Peg 2 Height(mm)Peg 3 Height(mm)Peg 1 Diameter(mm)2 36.48 33.39 10.0 10.0 10.0 6.53 38.70 35.53 10.5 10.5 10.5 6.54 40.93 37.65 11.0 11.0 11.0 6.55 43.15 39.87 11.5 11.5 11.5 6.56 45.38 42.06 12.0 12.0 12.0 6.57 47.60 44.22 12.5 12.5 12.5 6.58* 49.83 46.35 13.0 13.0 13.0 6.5*Size 8 is not a standard size, but is available as a special order.HeightPeg HeightWidth

Technical Data Sheet RESTORIS ® MCK MultiCompartmental Knee SystemPatellaSizeDiameter(mm)Thickness(mm)Peg Diameter(mm)Peg Length(mm)Peg Circle Diameter(mm)26 26 8.0 5.5 5.5 15.029 29 8.5 5.5 5.5 15.032 32 9.0 5.5 5.5 18.035 35 9.5 5.5 5.5 18.038 38 10.0 5.5 5.5 18.041 41 10.5 5.5 5.5 18.0ThicknessDiameterPeg LengthPeg DiameterPeg CircleDiameterRestoring Quality of Life Through Innovation®2555 Davie Road I Fort Lauderdale, FL 33317 I 866.647.6256 I www.makosurgical.com© MAKO Surgical Corp. 203012 r02 07/10