MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM

K082172 · Mako Surgical Corporation · HSX · Nov 28, 2008 · Orthopedic

Device Facts

• Record ID: K082172
• Device Name: MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
• Applicant: Mako Surgical Corporation
• Product Code: HSX · Orthopedic
• Decision Date: Nov 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces. The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.

Device Story

MMKC is a modular knee implant system comprising unicompartmental (MMKC-Uni) and patellofemoral (MMKC-PF) components. Used for medial tibiofemoral and/or patellofemoral replacement. System requires use with MAKO Tactile Guidance System (TGS) for surgical implantation. Components include femoral, tibial inlay, tibial onlay, tibial baseplate, and patellar implants in various sizes. Materials include CoCr, UHMWPE, and Ti6Al4V. Instrumentation (sizers, templates, trials, drills, etc.) provided in reusable trays. Device is implanted by surgeons in an OR setting using bone cement. TGS provides tactile guidance to assist in precise component placement. Benefits include restoration of joint function in patients with degenerative or post-traumatic arthritis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material biocompatibility per ASTM standards, and design comparison to legally marketed predicate devices.

Technological Characteristics

Materials: CoCr (femoral/patellofemoral), UHMWPE (inlay/onlay/patella), Ti6Al4V (baseplate), Titanium wire (marker). Components: Modular femoral, tibial, and patellar implants. Sterilization: Gamma radiation for implants; steam for instrumentation. Connectivity: Requires integration with MAKO Tactile Guidance System (TGS). Biocompatibility: Compliant with recognized ASTM standards.

Indications for Use

Indicated for individuals with osteoarthritis or post-traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces requiring single or multi-compartmental knee replacement. Intended for use with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• MAKO Surgical Corp. Patellofemoral Knee Implant System (K080029)
• MAKO Surgical Corp. Unicondylar Knee Implant System II (K080368)
• Stryker Compartmental Knee System (K052917)
• Depuy Graduated Compartmental Knee (K061648)
• DePuy GCK Femoral and Tibial Components (K070849)

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, sans-serif font. Below the word "MAKO" is the text "SURGICAL CORP" in a smaller font size. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a mountain peak.

NOV 28 2008

2555 Davie Road • Ft. Lauderdale, FL 33317 • Phone [phone] • www.makosurgical.com..

## ATTACHMENT 3 - 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: | July 30, 2008 |
| Proprietary Name: | MAKO Surgical Corp. Compartmental Knee Implant System (MMKC) |
| 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<br>HSX - Knee joint femorotibial metal/polymer non-constrained cemented<br>prosthesis; 21 CFR 888.3520<br>NPJ - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis; 21 CFR 888.3560<br>HRY - Knee joint femorotibial metal/polymer semi-constrained cemented<br>prosthesis: 21 CFR 888.3530 |

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

| Feature | MAKO Surgical Corp. Compartmental Knee Implant System (MMKC) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Components | MMKC-Uni Femoral component Tibial inlay component Radiographic marker in tibial inlay component Tibial onlay insert component Tibial baseplate MMKC-PF Patellofemoral component Patella component |
| Sizes | MMKC-Uni Femoral components are available in 8 sizes. Tibial components are available in 8 sizes. MMKC-PF Patellofemoral components available in 8 sizes. The patella components are available in 6 sizes. |
| Materials | MMKC-Uni Femoral component - CoCr Tibia Inlay component - UHMWPE Radiographic marker in tibial inlay component- Titanium wire Tibia onlay insert component - UHMWPE Tibial Baseplate - Ti6Al4V MMKC-PF Patellofemoral component - CoCr Patella component - UHMWPE |
| Instrumentation | Provided separately in a re-usable/sterilizable tray. Tray includes various tools<br>(e.g., sizers, templates, trials, drill, gage, impactors, inserters, extractors) used<br>during surgery. MMKC, MMKC-Uni, MMKC-PF can only be used with the MAKO<br>Tactile Guidance System (TGS) |

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Image /page/1/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a stylized mountain peak.

2555 Davie Road . • Ft. Lauderdale, FL 33317 . • Phone [phone] • www.makosurgical.com..

| Sterilization and Packaging | Sterilization:<br>• All components - gamma radiation<br>• Instrumentation - steam sterilization<br>Packaging:<br>• 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: The MAKO Surgical Corp. Compartmental Knee Implant System is substantially equivalent to MAKO Surgical Corp.'s Patellofemoral Knee Implant System (K080029); MAKO Surgical Corp.'s Unicondylar Knee Implant System II (K080368); Stryker® Compartmental Knee System (K052917); Depuy Graduated Compartmental Knee (K061648) and DePuy GCK Femoral and Tibial Components (K070849)

## Indications for Use:

The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces.

The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

NOV 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAKO Surgical Corp. % Mr. William F. Tapia Vice President, Regulatory 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K082172

Trade/Device Name: MAKO Modular Knee Compartmental Implant System (MMKC) Regulation Number: 21 CFR 888.3560 Regulation Name: Knec joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: NPJ, KRR, IISX, HRY Dated: November 18, 2008 Received: November 19, 2008

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 cither class II (Special Controls) or class III (PMA), it may be subject to such 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 further 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); good manufacturing practice requirements as set

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Page 2 - Mr. William F. Tapia

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,

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to logally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compulario at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological 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, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a mountain peak. The logo is black and white.

2555 Davie Road · Et. Lauderdale, FL 33317 · Phone [phone] · www.makosurgical.com_

## ATTACHMENT 2

## INDICATIONS FOR USE

510(k) Number (if known): K082172

Device Name: MAKO Modular Knee Compartmental Implant System (MMKC)

Indications for Use:

The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral articular sufaces.

The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.

X 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)

. . . . .

. '

Mark A. Melhers

.

.

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number

. . . .