ADVANCE LESS CONFORMING TIBIAL COMPONENT

K030193 · Wrightmedicaltechnologyinc · HRY · Feb 20, 2003 · Orthopedic

Device Facts

• Record ID: K030193
• Device Name: ADVANCE LESS CONFORMING TIBIAL COMPONENT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRY · Orthopedic
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact. The ADVANCE® Unicondylar Knee System components are for single use only. The ADVANCE® Unicondylar Knee System components are for cemented use only.

Device Story

ADVANCE® Less Conforming Tibial Component is a prosthetic implant for unicompartmental knee arthroplasty. Device consists of ultra-high molecular weight polyethylene (UHMWPE). Intended for cemented use in patients with intact ligaments. Surgeon selects component based on patient-specific requirements for less conforming tibial geometry. Implant replaces damaged joint surfaces to reduce pain and restore function. Device is single-use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Material: Ultra-high molecular weight polyethylene (UHMWPE). Form factor: Tibial component for unicompartmental knee system. Energy source: None (mechanical implant). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for pain relief or improved function due to noninflammatory/inflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis), functional deformity, failed prior treatments, or unmanageable fractures. Specifically for unicompartmental joint disease with intact ligaments, with or without valgus, varus, or flexion deformities.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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FEB 2 0 2003

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" formed by three thick, angled lines on the left. To the right of the "W" is the text "WRIGHT MEDICAL TECHNOLOGY" stacked vertically in three lines. The font is a serif typeface, and the entire logo is in black.

A Wright Medical Group Company

K030193
Page 1 of 2

# 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 ADVANCE® Less Conforming Tibial Component.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------------|
| Date: | January 15, 2003 |
| Contact Person: | Tim Crabtree<br>Senior Regulatory Affairs Specialist<br>Phone: [phone] Fax: [phone] |
| Proprietary Name: | ADVANCE® Less Conforming Tibial Component |
| Common Name: | Unicondylar Knee System |
| Classification Name and Reference: | 21 CFR 888.3530 Prosthesis |
| Device Product Code and Panel Code: | Orthopedics/87/HRY |

### DEVICE INFORMATION

#### A. INTENDED USES/ INDICATIONS

### 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.

Image /page/0/Picture/15 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL" stacked on top of "TECHNOLOGY". Below the logo is the text "A Wright Medical Group Company".

Image /page/0/Picture/16 description: The image shows a black and white drawing of a person's face in profile. The person has a prominent nose and chin, and their hair is pulled back. The drawing is somewhat stylized, with bold lines and shading. The person's expression is neutral.

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Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.

The ADVANCE® Unicondylar Knee System components are for single use only.

The ADVANCE® Unicondylar Knee System components are for cemented use only.

### B. DEVICE DESCRIPTION

The ADVANCE® Unicondylar Knee System Less Conforming Tibial Component will be offered based on surgeon preference and patients requiring less conforming tibial components. The tibial components will consist of all poly ultra high molecular weight polyethylene (UHMWPE).

The design features of ADVANCE® Less Conforming Tibial Component are substantially equivalent to the design features of previously cleared predicate devices cited in this Premarket Notification.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, and design features of the ADVANCE® Less Conforming Tibial Component are substantially equivalent to the previously cleared predicate devices cited in this submission. The safety and effectiveness of the ADVANCE® Less Conforming Tibial Component is adequately supported by the substantial equivalence information, materials, and testing results provided within this Premarket Notification.

Image /page/1/Picture/9 description: The image shows a black and white illustration of a human torso. The torso is in a side view, and the internal organs are visible. The organs include the lungs, heart, liver, and intestines. The illustration is detailed and appears to be from an anatomy textbook.

Image /page/1/Picture/10 description: The image shows the logo for Wright Medical Technology. The logo features a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Mr. Tim Crabtree Senior Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

Re: K030193 Trade/Device Name: ADVANCE® Less Conforming Tibial Component Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: January 17, 2003 Received: January 21, 2003

Dear Mr. Crabtree:

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 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,

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Page 2 - Mr. Tim Crabtree

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. 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 Wright Medical Technology. The logo consists of a stylized "W" formed by three thick, angled bars on the left. To the right of the "W" are the words "WRIGHT MEDICAL TECHNOLOGY" stacked vertically in a serif font. The word "WRIGHT" is on top, followed by "MEDICAL" and then "TECHNOLOGY".

A Wright Medical Group Company

# ADVANCE® Less Conforming Tibial Component

K030193
Page 1 of 1

#### INDICATIONS STATEMENT

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;
- correction of functional deformity; 3)
- 4) revision procedures where other treatments or devices have failed; and
- 5) treatment of fractures that are unmanageable using other techniques.

Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.

The ADVANCE® Unicondylar Knee System components are for single use only.

The ADVANCE® Unicondylar Knee System components are for cemented use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

eral. Restorative and Neurologic

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Prescription Use
(Per21 CFR 801.10510(k) Number K0309R93

Over-The Counter Use (Optional Format 1-2-96)

Image /page/4/Picture/21 description: The image shows the logo for Wright Medical Technology. The logo consists of a large, stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo, there is the text "A Wright Medical Group Company".

Image /page/4/Picture/22 description: The image shows the text "INDICATIONS STATEMENT.doc" in a serif font. The text is black and is set against a white background. The text appears to be a file name, likely a document related to indications statements.

Image /page/4/Picture/23 description: The image is a black and white illustration of a human torso. The torso is in a side view, and the internal organs are visible. The lungs, heart, and other organs are clearly visible. The image is likely from a medical textbook or other educational material.