PROVEN REVISION MODULAR TIBIAL TRAY

K051976 · Stelkast Company · JWH · Oct 17, 2005 · Orthopedic

Device Facts

• Record ID: K051976
• Device Name: PROVEN REVISION MODULAR TIBIAL TRAY
• Applicant: Stelkast Company
• Product Code: JWH · Orthopedic
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications: 1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; 2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.

Device Story

StelKast Proven Revision Modular Tibial Tray is a prosthetic component for total knee arthroplasty. Device functions as a mechanical implant to replace damaged joint surfaces; intended for cemented fixation. Used by orthopedic surgeons in clinical/hospital settings during knee replacement or revision surgery. Provides structural support and articulation surface for knee joint; restores joint function; alleviates pain associated with degenerative conditions or failed prior implants. Device is a modular component designed to integrate with existing knee reconstruction systems.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular tibial tray for cemented total knee replacement. Metal/polymer construction. Designed for semi-constrained application. Class II device under 21 CFR 888.3560.

Indications for Use

Indicated for patients requiring total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, post-traumatic degenerative conditions, or revision of failed prior reconstructions with adequate bone stock and soft tissue integrity. For cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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Public Health Service

0CT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Donald A. Stevens President StelKast Company 200 Hidden Valley Road McMurray, Pennsylvania 15317

Re: K051976

Trade/Device Name: StelKast Proven Revision Modular Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 07, 2005

Received: October 11, 2005

Dear Mr. Stevens:

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- Donald A. Stevens

This letter will allow you to begin marketing your device as described in your Section 510(k) rms reket 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/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson Acting 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

510(k) Number (if known): K051976

Device Name: StelKast Proven Revision Modular Tibial Tray

Indications for Use:

The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications:

- 1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
- 2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_Kos Ta Je

(Posted November 13, 2003)