RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM

K090763 · Mako Surgical Corporation · NPJ · Jun 17, 2009 · Orthopedic

Device Facts

• Record ID: K090763
• Device Name: RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
• Applicant: Mako Surgical Corporation
• Product Code: NPJ · Orthopedic
• Decision Date: Jun 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: - Medial unicondylar . - . Lateral unicondylar - Patellofemoral - Medial bi-compartmental (medial unicondylar and patellofemoral) RESTORIS MCK is for single use only and is intended for implantation with bone cement.

Device Story

Restoris MCK is a modular knee prosthesis system comprising unicompartmental (Uni) and patellofemoral (PF) components. Used exclusively with MAKO Robotic Arm Interactive Orthopedic System (RIO) for surgical planning and execution. Components include femoral condyles, tibial inlays/baseplates, patellofemoral components, and patella components. Materials include CoCrMo alloy, UHMWPE, and Ti6Al4V ELI. System allows for medial/lateral unicondylar, patellofemoral, or medial bi-compartmental replacements. Instrumentation (sizers, templates, trials, drills) provided for use with RIO. Intended for cemented implantation. Benefits include precise component placement via robotic assistance, potentially improving alignment and patient outcomes in knee arthroplasty.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility testing per recognized ASTM standards and mechanical performance verification of the implant components and instrumentation.

Technological Characteristics

Materials: CoCrMo alloy, UHMWPE, Ti6Al4V ELI, unalloyed titanium wire. Components: Femoral condyle, tibial inlay/baseplate, patellofemoral, patella. Sterilization: Gamma radiation (implants), steam (instruments). Connectivity: Requires integration with MAKO RIO robotic system. Form factor: Modular multi-compartmental knee prosthesis.

Indications for Use

Indicated for individuals with osteoarthritis or post-traumatic arthritis of tibiofemoral and/or patellofemoral articular surfaces requiring single or multi-compartment knee replacement. Configurations include medial/lateral unicondylar, patellofemoral, or medial bi-compartmental replacement. Must be used with RIO Robotic Arm Interactive Orthopedic System and bone cement.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• MAKO Modular Knee System (K082172)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP" in smaller letters underneath. Above the word "MAKO" is a stylized graphic that resembles a mountain range. The text "KD9" is written in the upper right corner of the image.

JUN 1 7 2009

2555 Davie Road . Et. Lauderdale, El, 33317. . . Phone 954,927,2044 . Fax 954,927,0446 . . www.makosurgical.com ...

### 510(K) SUMMARY

| Submitter: | MAKO Surgical Corp. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number / Fax Number: | (Ph) 954-927-2044 x 605; (F) 954-927-0446 |
| Contact Person: | William F. Tapia |
| Date Prepared: | March 18, 2009 |
| Proprietary Name: | Restoris MultiCompartmental Knee System (Restoris MCK) |
| Common Name: | Compartmental Knee Prosthesis System |
| Classification: | Class II |
| Product Code / #: | KRR - Knee joint patellofemoral polymer/metal semi-constrained cemented<br>prosthesis; 21 CFR 888.3540 |
| | HSX - Knee joint femorotibial metal/polymer non-constrained cemented<br>prosthesis; 21 CFR 888.3520 |
| | NPJ - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis; 21 CFR 888.3560 |
| | HRY - Knee joint femorotibial metal/polymer semi-constrained cemented<br>prosthesis; 21 CFR 888.3530 |

Description: The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

| Feature | Restoris MCK |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Components | Restoris MCK Uni Femoral Condyle component Tibial Inlay component Radiographic marker in Tibial Inlay component Tibial Onlay Insert component Tibial Baseplate |
| | Restoris MCK PF Patellofemoral component Patella component |
| Sizes | Restoris MCK Uni Femoral Condyle components are available in 8 sizes. Tibial components are available in 8 sizes. Restoris MCK PF Patellofemoral components available in 8 sizes. Patella components are available in 6 sizes. |
| Materials | Restoris MCK Uni Femoral Condyle component – CoCrMo alloy Tibia Inlay component – UHMWPE Radiographic marker in Tibial Inlay component – Unalloyed titanium wire Tibia Onlay Insert component – UHMWPE Tibial Baseplate – Ti6Al4V ELI alloy Restoris MCK PF Patellofemoral component – CoCrMo alloy Patella component – UHMWPE |
| Instrumentation | Provided separately in a re-usable/sterilizable tray. Tray includes various tools<br>(e.g., sizers, templates, trials, drills, gauges, impactors, inserters, extractors) used<br>during surgery. Restoris MCK can only be used with the MAKO Robotic Arm<br>Interactive Orthopedic System (RIO) |

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Image /page/1/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a stylized image of a mountain range. The mountain range is shaded with a gradient, with the top of the mountains being lighter than the bottom.

2555 Davie Road_ * . Et. Lauderdale, FL 33317 . • Phone [phone] . • Fax [phone] . • www.makosurgical.com...

| Sterilization and Packaging | Sterilization:<br>o All components – gamma radiation<br>o Instrumentation – steam sterilization<br>Packaging:<br>o All components are supplied in double sealed containers maintaining double<br>sterile barriers. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All components are made of materials for surgical implant applications per<br>recognized ASTM standards. |

Substantial Equivalence: Restoris MCK is substantially equivalent to the MAKO Modular Knee System (K082172).

Indications for Use:

RESTORIS MCK is indicated for single or multi-compartment used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

- Medial unicondylar · .
- Lateral unicondylar .
- Patellofemoral .
- Medial bi-compartmental (medial unicondylar and patellofemoral) .

RESTORIS MCK is for single use only and is intended for implantation with bone cement.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 7 2009

MAKO Surgical Corporation % Mr. William F. Tapia 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K090763

Trade/Device Name: Restoris MultiCompartmental Knee System (Restoris MCK) Regulation Number: 21 CFR 888.3560

Regulation Name: Knee ioint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis

Regulatory Class: Class II Product Code: NPJ, KRR, HSX, HRY Dated: March 17, 2009 Received: March 23, 2009

Dear Mr. Tapia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish farther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting

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Page 2-Mr. William F. Tapia

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehr

Mark N. Mellman

Mark N. Melkerson Director . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP" in smaller letters underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a mountain peak. The logo is simple and modern, and it conveys a sense of strength and precision.

# 2555 Davie Road

### INDICATIONS FOR USE

510(k) Number (if known): K090763

Device Name: Restoris MultiCompartmental Knee System (Restoris MCK)

Indications for Use:

RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

- Medial unicondylar .
- . Lateral unicondylar
- Patellofemoral
- Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS MCK is for single use only and is intended for implantation with bone cement.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart.C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oputa
(Division Sign-Off)

(Division Sign-6 (Division Sign-Ord), Orthopedic, Divisionative Devices

510(k) Number K090763