DEPUY PRESERVATION UNICONDYLAR TIBIA

K040268 · DePuy Orthopaedics, Inc. · HRY · May 5, 2004 · Orthopedic

Device Facts

• Record ID: K040268
• Device Name: DEPUY PRESERVATION UNICONDYLAR TIBIA
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Preservation™ Unicondylar Knee is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Caution: This knee prosthesis component is intended for cemented use only. Candidates for unicondylar knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicondylar knee arthroplasty, only one side of the joint (the medial or lateral compartmental) is affected. Unicondylar knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Device Story

The DePuy Preservation™ Unicondylar Tibia is a knee prosthesis component designed for cemented unicondylar knee arthroplasty. It consists of a polyethylene insert that attaches to a Co-Cr-Mo tibial tray via a posterior tab and anterior clips. The tray features a grooved single keel for fixation. The device is available in five sizes and three thicknesses, designed to articulate with the DePuy Preservation Unicondylar Knee femoral component. It is implanted by orthopedic surgeons in a clinical/surgical setting to replace damaged joint surfaces, aiming to restore mobility and reduce pain in patients with single-compartment joint disease. The device provides a mechanical bearing surface to replace the natural joint articulation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices.

Technological Characteristics

Materials: Polyethylene insert, Co-Cr-Mo tibial tray. Design: Semi-constrained, cemented, metal/polymer knee prosthesis. Features: Grooved single keel for fixation, posterior tab and anterior clip assembly. Dimensions: 5 sizes, 3 thicknesses (9.5, 11.5, 13.5 mm). Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients with damaged knee joint articulation requiring increased mobility and pain reduction. Applicable to elderly patients with severe joint pain/disability due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants. Suitable for younger patients if surgical indication outweighs age-related risks and activity demands are limited. Restricted to patients with sufficient sound bone for component seating and single-compartment (medial or lateral) involvement. Cemented use only.

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).

Predicate Devices

• DePuy Preservation™ Unicondylar Knee System (K010810)
• PFC® Sigma Uni-Compartmental Knee System (K954481)

Submission Summary (Full Text)

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MAY - 5 2004

K040268/51

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SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>EST REG No.: 1818910 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Abraham Wright<br>Project Engineer<br>Tel: [phone]<br>Fax: [phone] |
| TRADE NAME: | DePuy Preservation™ Unicondylar Tibia |
| COMMON NAME: | Unicompartmental Knee Prosthesis |
| CLASSIFICATION: | Knee joint femorotibial, metal/polymer semi-constrained<br>cemented prosthesis (per 21 CFR 888.3530), Class II<br>Device |
| DEVICE PRODUCT CODE: | 87 HRY |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Preservation™ Unicondylar Knee System<br>(K010810, cleared April 18, 2001)<br>PFC® Sigma Uni-Compartmental Knee System<br>(K954481, cleared October 10, 1996) |

## DEVICE DESCRIPTION:

The DePuy Preservation™ Unicondylar Tibia consists of a polycthylene insert that assembles to Co-Cr-Mo tibial tray. The insert has a posterior tab and anterior clips that connect to the peripheral rim of the tray. The undersurface of the tibia tray consists of a grooved single keel that runs anterior-posterior and is designed to provide fixation. It is available in five sizes, 1 through 5, and in three thicknesses, 9.5, 11.5, and 13.5 mm. All insert sizes are designed to articulate with all five sizes of the DePuy Preservation Unicondylar Knec femoral component.

## INDICATIONS FOR USE:

The Delluy Preservation Unicondylar Knce is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Caution: This knee prosthesis component is intended for cemented use only. Candidates for unicondylar knec replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for

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unicondylar knee arthroplasty, only one side of the joint (the medial or latcral compartmental) is affected. Unicondylar knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

## SUBSTANTIAL EQUIVALENCE:

The fundamental scientific technologies of the DePuy Preservation Unicondylar Tibia Prosthesis have not changed from the FDA cleared DePuy Preservation Unicondylar Knce System (K010810) and PFC Sigma Uni-Compartmental Knee System (K954481). They have the same intended use, indications, sterilization method, packaging, method of manufacture, and similar materials and designs. DePuy believes that the DePuy Preservation Unicondylar Tibia is substantially equivalent to the FDA cleared DePuy Preservation Unicondylar Knee System (K010810) and the PFC Sigma Uni-Compartmental Knee System (K954481).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the circle is an emblem that features a stylized eagle or bird-like figure with three wing-like shapes above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 5 2004

Abraham Wright Project Engineer DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K040268

Trade/Device Name: DePuy Preservation™ Unicondylar Tibia Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: April 2, 2004 Received: April 5, 2004

Dear Mr. Wright:

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 he 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 adviscd 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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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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsmarnain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative

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

| 510(k) Number (if known): | K040268 |
|---------------------------|---------|
| Device Name: | |

Indications for Use:

The DePuy Preservation™ Unicondylar Knee is intended to provide increased patient rnobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Caution: This knee prosthesis component is intended for cemented use only. Candidates for unicondylar knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicondylar knee arthroplasty, only one side of the joint (the medial or lateral compartmental) is affected. Unicondylar knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Prescription Use
(Part 21 CFR 801 Subpart D) for Mark
Concurrence of DBRH
(Division Sign-Off)
Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
510(k) Number
K040268
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