RESTORIS® MCKMultiCompartmental Knee System

Technical Data Sheet

Innovative 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 recovery

Modularity Replaces Only the Diseased Compartments• Unicondylar, Patellofemoral, and Bicompartmental options• Removes significantly less bone, preserving bone stock

Contoured Surfaces• Implant shapes designed from analysis of over 100 knee CT scans• Anatomic sculpted resection enabled by RIO® Robotic Arm Interactive Orthopedic System

Patient Specific Fit• Six standard implant sizes provide a modular customized fit• Components positioned to patient specific anatomy for optimal patella tracking andpatella transitioning

Intra-operative Flexibility• Tibial-femoral full size compatibility• Patellofemoral-patella full size compatibility• Patellofemoral-femoral 1 up / 1 down compatibility

*RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand.

Technical Data Sheet RESTORIS® MCK MultiCompartmental Knee System

Indications for use1

• 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 System2, 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 System

*RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand. The third-party trademarks used herein are trademarks of their respective owners.

Patellofemoral /Femoral

Tibial Inlay Tibial Onlay Patella Dome

Material Cobalt chromium (CoCr)alloy per ASTM F75

Tibial Inlay:Ultra-high molecular-weightpolyethylene (UHMWPE) perASTM F648- GUR 1050, resin type 2- Compression molded

Radiographic Marker:Titanium wire per ASTMF67

Onlay Insert:Ultra-high molecular weightpolyethylene (UHMWPE) perASTM F648- GUR 1050, resin type 2- Compression molded

Onlay Baseplate:Titanium alloy per ASTMF136

Ultra-high molecular-weightpolyethylene (UHMWPE) perASTM F648- GUR 1050, resin type 2- Compression molded

ManufacturingProcess

Cast, heat-treated- Articular surface:polished

- Cement-contactingsurface: grit blasted

Machined from stockmaterial

Onlay Insert:Machined from stockmaterial

Onlay Baseplate:Machined from stockmaterial- Locking surface: satinfinish

- Cement-contactingsurface: grit blasted

Machined from stockmaterial

Packaging Tyvek/Mylar inner andouter pouches

Foil inner pouch- Prior to sealing,environmental oxygen(air) is purged with inertgas- Impermeable, preventingre-entry of oxygen

Tyvek/Mylar outer pouch

Onlay insert:Foil inner pouch- Prior to sealing,environmental oxygen(air) is purged with inertgas

- Impermeable, preventingre-entry of oxygen

Tyvek/Mylar outer pouchOnlay baseplate:Tyvek/Mylar inner and outerpouches

Foil inner pouch- Prior to sealing,environmental oxygen(air) is purged with inertgas

- Impermeable, preventingre-entry of oxygen

Tyvek/Mylar outer pouch

Sterilization Gamma, 2.5 – 4.0 Mrad

Shelf Life 5 years

Technical Data Sheet RESTORIS® MCK MultiCompartmental Knee System

Femoral Condyle

Size AP (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 0.0

2 45.0 17.0 33.1 4.0 6.0 9.75 12.0 6.5 0.0

3 48.0 18.0 35.4 4.0 6.2 10.50 13.0 6.5 0.5

4 51.0 19.0 37.6 4.0 6.4 11.25 14.0 6.5 1.0

5 54.0 20.0 39.9 4.0 6.6 12.00 15.0 6.5 1.5

6 57.0 21.0 42.1 4.0 6.8 12.75 16.0 6.5 2.0

7 60.0 22.0 44.4 4.0 7.0 13.50 17.0 6.5 2.5

8* 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.

ML

Posterior Thickness

Peg Diameter

Peg 2 Height

Peg 1 Height

Condylar Height

AP

Technical Data Sheet RESTORIS® MCK MultiCompartmental Knee System

Size AP (mm) ML (mm) Thickness (mm)

1* 30.0 17.5 6.5 7.5 8.5

2 33.0 19.0 6.5 7.5 8.5

3 36.0 20.5 6.5 7.5 8.5

4 39.0 22.0 6.5 7.5 8.5

5 42.0 23.5 6.5 7.5 8.5

6 45.0 25.0 6.5 7.5 8.5

7 48.0 26.5 6.5 7.5 8.5

8* 51.0 28.0 6.5 7.5 8.5

*Size 1 and 8 are not standard sizes, but are available as special order.

Tibial Inlay

AP

ML

Thickness

*RESTORIS MCK Inlay component is not approved for use in Australia and New Zealand.

Technical Data Sheet RESTORIS® MCK MultiCompartmental Knee System

SizeBaseplate 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 10.0

2 41.0 37.5 23.0 7.0 6.5 30 5.0 8.0 9.0 10.0

3 44.0 40.3 24.5 7.0 6.5 30 5.0 8.0 9.0 10.0

4 47.0 43.0 26.0 7.0 6.5 30 5.0 8.0 9.0 10.0

5 50.0 45.8 27.5 8.0 6.5 30 6.0 8.0 9.0 10.0

6 53.0 48.5 29.0 8.0 6.5 30 6.0 8.0 9.0 10.0

7 56.0 51.3 30.5 8.0 6.5 30 6.0 8.0 9.0 10.0

8* 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.

Tibial Onlay

Thickness

Keel Height

Insert AP

BaseplateAP

BaseplateInsertML

Peg Height

Peg Diameter

Peg Angle

Size 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 6.5

3 38.70 35.53 10.5 10.5 10.5 6.5

4 40.93 37.65 11.0 11.0 11.0 6.5

5 43.15 39.87 11.5 11.5 11.5 6.5

6 45.38 42.06 12.0 12.0 12.0 6.5

7 47.60 44.22 12.5 12.5 12.5 6.5

8* 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.

Technical Data Sheet RESTORIS® MCK MultiCompartmental Knee System

Patellofemoral

Peg Height

Height

Width

© MAKO Surgical Corp. 203012 r02 07/10

2555 Davie Road I Fort Lauderdale, FL 33317 I 866.647.6256 I www.makosurgical.comRestoring Quality of Life Through Innovation®

Technical Data Sheet RESTORIS® MCK MultiCompartmental Knee System

SizeDiameter(mm)

Thickness(mm)

Peg Diameter(mm)

Peg Length(mm)

Peg Circle Diameter(mm)

26 26 8.0 5.5 5.5 15.0

29 29 8.5 5.5 5.5 15.0

32 32 9.0 5.5 5.5 18.0

35 35 9.5 5.5 5.5 18.0

38 38 10.0 5.5 5.5 18.0

41 41 10.5 5.5 5.5 18.0

Patella

Peg Diameter

Peg Length

DiameterThickness

Peg CircleDiameter

Stryker New Zealand Limited515 Mt. Wellington HighwayAuckland 1060 New ZealandPh: +64 9 573 1890www.stryker.com

Stryker Australia Pty Ltd8 Herbert Street St Leonards NSW 2065 AustraliaPh: +61 2 9467 1000 www.stryker.com.au

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.

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.

whether to use of an

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 use of any particular product before using it in surgery.