ADVANCE TOTAL KNEE SYSTEM

K061223 · Wrightmedicaltechnologyinc · MBH · Aug 18, 2006 · Orthopedic

Device Facts

• Record ID: K061223
• Device Name: ADVANCE TOTAL KNEE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBH · Orthopedic
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADVANCE® Total Knee System is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Total Knee System components are for use without bone cement and are single use devices.

Device Story

ADVANCE® Total Knee System is a prosthetic knee joint replacement system; components include femoral, tibial, and patellar implants. Manufactured from Cobalt Chrome or Titanium alloys; features porous coating for cementless fixation; optional Hydroxyapatite (HA) coating. Intended for surgical implantation by orthopedic surgeons in hospital settings to replace damaged knee joints. Device restores joint function and reduces pain in patients with degenerative or inflammatory joint disease, deformity, or fractures. System is compatible with existing ADVANCE® tibial inserts and patellas. Single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by materials data and bench testing results.

Technological Characteristics

Materials: Cobalt Chrome Alloy, Titanium Alloy. Features: Porous coating, optional HA coating. Design: Patellofemorotibial metal/polymer prosthesis. Configuration: Uncemented. Sterilization: Not specified. Connectivity: N/A. Software: None.

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for pain relief or improved function due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, failed prior treatments, or unmanageable fractures.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Submission Summary (Full Text)

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Ko61223 (pg 1 of 2)

AUG 1 8 2006

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® Total Knee System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Date: | May 1, 2006 |
| Contact Person: | Theresa Leister<br>Regulatory Affairs Specialist II |
| Proprietary Name: | ADVANCE® Total Knee System |
| Common Name: | KNEE SYSTEM |
| Classification Name and Reference: | 21 CFR 888.3565 Knee joint Patellofemorotibial<br>Metal/Polymer Porous-Coated Uncemented Prosthesis -<br>Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ MBH |

#### DEVICE INFORMATION

#### A. INTENDED USE

The ADVANCE® Total Knee System is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and
- 5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Total Knee System components are for use without bone cement and are single use devices.

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Special 510(k)
**ADVANCE® Total Knee System**
510(K) SUMMARY
Page 2 of 2

K061223 (pg 2 of 2

## B. DEVICE DESCRIPTION

The ADVANCE® Total Knee System contains femoral components, tibial components, and The ADVANCE® Total Rice System comanis telleries System components are compatible with existing ADVANCE® tibial inserts and patellas. The design features and function of the with existing ADVANCE® tiolar meetis are substantially equivalent to the design features ADVANCE® Total Rice bystem of more the ADVANCE® Total Knee System and are highlighted below.

- Manufactured from Cobalt Chrome Alloy or Titanium Alloy .
- Manufactured with porous coating .
- Accessory components available without porous coating .
- Available with or without HA coating .
- Intended for use without bone cement .

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of ADVANCE® Total Knee The miended use, material, type of merently available ADVANCE® Total Knee System System are substantially equivateli vo shoot of ADVANCE® Total Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 8 2006

Wright Medical Technology, Inc. c/o Ms. Theresa Leister Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K061223

Trade/Device Name: ADVANCE® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: July 18, 2006 Received: July 19, 2006

Dear Ms. Leister:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications referenced above and nave determined the arroomedicate devices marketed in interstate for use stated in the enclosure) to tegally manatiment profice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the characters with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provision and capital devices that have been reclassified in accordance with as persualset approval application (PMA).
and Cosmetic Act (Act) that do not require approval as a providions of the Ac and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, belyer to use going mishranding and general controls provisions of the field be prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo chirola crain and many of the can and clevice can
may be subject to such additional controls. Title may be subject to such additional controls. Extems, majors 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 Postser be found in the Code of Peacharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buocation with other requirements of the Act
that FDA has made a determination that your device complies with openains. You must that FDA nas made a determination and your correst by other Federal agencies. You must a or any Federal statures and regulations administered of other its registration and listing (21
comply with all the Act's requirements, including, but not areas as set comply with all the Act STequirements, merceinig, career and surfice requirements as set

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Page 2 - Ms. Theresa Leister

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roganation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (Sections 991 - 12 - 25 - 12 - 11 - 10 -I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. The PDA miding of sabsantal equice 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 If you desire specific advice for your device to a Also, please note the regulation entitled, contact the Office of Complanoo at (210) 216-616 Part 807.97). You may obtain "Misbranding by relevence to premarket noutheaders in the Act from the Division of Small other general information on your responsion.com its toll-free number [phone] or Manufacturers, International and Consumer Fisciblance area confecth/industry/support/index.html.

Sincerely yours,

Joubay Onuchin

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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### Indications for Use

14061223 510(k) Number (if known):

Device Name: ADVANCE® Total Knee System

Indications For Use:

The ADVANCE® Total Knee System is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;

inflammatory degenerative joint disease including rheumatoid arthritis; 2)

correction of functional deformity; 3)

revision procedures where other treatments or devices have failed; and 4)

5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Total Knee System components are for use without bone cement and are single use devices.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Barbara Buchup

Division of General, Restorative, and Neurological Devices

K061223

510(k) Number