ADVANCE UNICONDYLAR KNEE SYSTEM

K012591 · Wrightmedicaltechnologyinc · HRY · Nov 2, 2001 · Orthopedic

Device Facts

• Record ID: K012591
• Device Name: ADVANCE UNICONDYLAR KNEE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRY · Orthopedic
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Abbreviated
• 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: 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

The ADVANCE® Unicondylar Knee System is a cemented, non-constrained/semi-constrained femorotibial prosthesis used in knee arthroplasty. It consists of anatomically shaped, nonporous Cobalt-Chromium (Co-Cr) femoral components and all-polyethylene (UHMWPE) tibial components. The femoral component is available in four sizes with left/right configurations; the tibial component is available in four universal sizes. The device is intended for single-use implantation by orthopedic surgeons to relieve pain and improve knee function in patients with unicompartmental joint disease. It functions as a mechanical replacement for the joint surface, secured via bone cement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Cobalt-Chromium (femoral), UHMWPE (tibial). Design: Anatomically shaped, nonporous femoral components; universal tibial components. Interface: Cemented. Configuration: Non-constrained/semi-constrained femorotibial prosthesis.

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for unicompartmental joint disease (osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis), functional deformity, revision, or unmanageable fractures. Requires intact ligaments; may be used with 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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K0/259/

NOV 0 2 2001

## 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® Unicondylar Knee System.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

August 9, 2001

Ehab M. Esmail Manager, Regulatory Affairs

ADVANCE® Unicondylar Knee System

UNICONDYLAR KNEE SYSTEM

21 CFR 888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer -Class II

21 CFR 888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer -Class II

Device Product Code and Panel Code:

Orthopedics/87/ HSX, HRY

### DEVICE INFORMATION

#### A. 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:

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

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IOFD

51000 SUMMARY

KNIGHT
AL TECHNOLOGY, INC.

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K012591
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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 contains anatomically shaped, medial, nonporous Co-Cr femoral components. The tibial components will consist of all-poly ultrahigh molecular-weight polyethylene (UHMWPE) tibial implants.

The ADVANCE® Unicondylar Femoral component will be available in four anatomic sizes (to provide coverage of the condyle from posterior to anterior). The anatomic shape of the femoral component necessitates separate left and right configurations.

The ADVANCE® Unicondylar Tibial component will be available in four sizes (universal in shape- no lefts and rights).

The design features of ADVANCE® Unicondylar Knee System are substantially equivalent to the design features of competitive devices previously cleared for market.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of ADVANCE® Unicondylar Knee System are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of ADVANCE® Unicondylar Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K012591

Trade/Device Name: ADVANCE® Unicondylar Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: August 9, 2001 Received: August 10, 2001

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becall be o(s) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use surved in the entrebate) 77 ttg enactment date of the Medical Device Amendments, or to conninered pror to 1125 2017 11:11 accordance with the provisions of the Federal Food, Drug, de rices that have been recises of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dierelove, mains 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 If your device is elabilitional controls. Existing major regulations affecting your device can may be back 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 r lease of acrised a determination that your device complies with other requirements of the Act that I Drives Internet and regulations administered by other Federal agencies. You must or mry receits 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 Of It Part 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in also quind provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Ehab M. Esmail

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgen mailsoning your and equivalence of your device to a legally premits that in the Pro Promating of 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 and II you desire specific advice for your dovitro diagnostic devices), please contact the Office of additionally 21 CF R Fart 607.10 for the market on the promotion and advertising of Compliance at [phone]. Additionally, 18 41-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation clittined, "Misoranang of responsibilities under the Act may be obtained from the Outler general information on your respectional 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,

L. Mark N. Milliman

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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NOV 0 2 2001

# ADVANCE® Unicondylar Knee System

## INDICATIONS STATEMENT

Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved Indicated for ass as as a leater 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;
- 3) convoluon of raires where other treatments or devices have failed; and
- 4) freatment 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 (OD

for Mark A. Millane

Division Sior Division of General Re Devices 510(k) Number

Prescription Use
(Per21 CFR 801.109) X

OR

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

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INDICATIONS STATEMENT

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