MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM

K073248 · Mako Surgical Corp. · HSX · Dec 12, 2007 · Orthopedic

Device Facts

• Record ID: K073248
• Device Name: MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
• Applicant: Mako Surgical Corp.
• Product Code: HSX · Orthopedic
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAKO Surgical Unicondylar Knee System, Additional Components is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

Device Story

Device consists of orthopedic knee implants for cemented, single-use reconstruction. System includes asymmetrical cast CoCr distal femoral components and symmetrical ultra-high molecular weight polyethylene (UHMWPE) tibial resurfacing components. Adds 'onlay' tibial inserts and baseplates to existing 'inlay' system. Used by surgeons in clinical settings to treat moderate knee joint impairment. Implants replace damaged articular surfaces to reduce pain and restore function. Benefit to patient includes joint reconstruction as alternative to osteotomy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Cast CoCr (femoral), UHMWPE (tibial). Design: Asymmetrical femoral components (5 sizes, left/right); symmetrical tibial components (5 sizes, 3 thicknesses: 6.5mm, 7.5mm, 8.5mm). Fixation: Cemented. Configuration: Onlay design for tibial ridge. Single-use.

Indications for Use

Indicated for patients with moderate joint impairment due to painful osteoarthritis or traumatic arthritis requiring cemented reconstruction of the medial or lateral femur and corresponding tibial surface; alternative to tibial osteotomy for unicompartmental arthritis; requires sufficient bone stock for implant seating.

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 Unicondylar Knee System (K060017)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 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 that resembles a shark fin or a mountain peak.

DEC 1 2 2007

2555 davie road fort lauderdale, florida 33317 tel [phone]

fax [phone]

## ATTACHMENT 1 510(K) SUMMARY

| Submitter: | MAKO Surgical Corp. |
|-----------------------------|--------------------------------------------------------------|
| Address: | 2555 Davie Road, Fort Lauderdale, FL, 33317 |
| Phone number: | 954-927-2044 x. 605 |
| Fax number: | 954-927-0446 |
| Contact Person: | William F. Tapia |
| Date Prepared: | November 16, 2007 |
| Cleared Device Trade Name: | MAKO Surgical Unicondylar Knee System |
| Modified Device Trade Name: | MAKO Surgical Unicondylar Knee System, Additional Components |
| Common Name: | Unicondylar knee |
| Classification Name: | Class II |
| Classification #: | 21 CFR 888.3520, Product Code: HSX |

Substantial Equivalence Claimed To: MAKO Surgical Unicondylar Knee System as described in MAKO Surgical Corp.'s K060017. The modification as described in this submission is shown to be substantially equivalent to the previously cleared system. As required by risk analysis, all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence.

Description and Summary of Technological Characteristics: This device consists of an asymmetrical cast CoCr distal femoral component and a symmetrical ultra-high molecular weight polyethylene tibial resurfacing component. These components are intended for cemented, one-time use only.

The femoral components are available in five sizes (1 through 5) and there is a left and right component for each size. There are five sizes of tibial components and each size is available in three thicknesses designated as 6.5mm, 7.5mm and 8.5mm. The thinnest section of the 6.5mm component is 6.0mm.

The additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the MAKO Surgical Unicondylar Knee System (K060017). The previously cleared device is an "inlay" designed unicondylar system where the polyethylene component sits inside the tibial cavity. The device described in this submission adds the "onlay" designed unicondylar components which sit on the tibial ridge.

Intended Use/Indications for Use : The MAKO Surgical Unicondylar Knee System, Additional Components is a single use device intended for cemented reconstruction of the medial femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

DEC 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAKO Surgical Corp. % Mr. William F. Tapia Vice President, RA/QA/CA 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K073248

Trade/Device Name: MAKO Surgical Unicondylar Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: November 16, 2007 Received: November 19, 2007

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 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

{2}------------------------------------------------

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 a legally marketed predicate device results in a classification for your device and thus, permits 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 Compliance 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 Postmarket 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark W. Wilkinson

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

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized mountain range above the company name. The text "MAKO" is in a bold, sans-serif font, and "SURGICAL CORP." is in a smaller, sans-serif font below it.

2555 davie road fort lauderdale, florida 33317 tel [phone] fax 954,927,0446

## ATTACHMENT 2

## INDICATIONS FOR USE

510(k) Number (if known): K073208

Device Name: MAKO Surgical Unicondylar Knee System, Additional Components

Indications for Use:

The MAKO Surgical Unicondylar Knee System, Additional Components is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

Prescription Use X

OR

Over-the-Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sarbar Barew

Division of C eral, Restorative, and Neurological Devices

**510(k) Number** K073248