PROVEN MODULAR TIBIAL TRAY

K030577 · Stelkast Company · JWH · Mar 25, 2003 · Orthopedic

Device Facts

• Record ID: K030577
• Device Name: PROVEN MODULAR TIBIAL TRAY
• Applicant: Stelkast Company
• Product Code: JWH · Orthopedic
• Decision Date: Mar 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present. For cemented use only.

Device Story

Proven Modular Tibial Tray is a component of a semi-constrained total knee system. Used in orthopedic surgery for total knee arthroplasty or revision procedures. Implanted by orthopedic surgeons in a hospital/OR setting. Device replaces damaged joint surfaces to restore function and reduce pain. Cemented fixation required. Benefits include joint stabilization and improved mobility for patients with degenerative joint disease or failed prior implants.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Modular tibial tray component for semi-constrained total knee prosthesis. Designed for cemented fixation. Metallic construction consistent with class II knee joint patellofemorotibial prostheses (21 CFR 888.3560).

Indications for Use

Indicated for patients requiring total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions, and for revision of failed previous reconstructions with sufficient 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).

Predicate Devices

• StelKast Proven Cemented, Semi-Constrained Total Knee System (K980276)
• StelKast Proven Cemented, Semi-Constrained Total Knee System (K000113)

Submission Summary (Full Text)

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MAR 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030577

Trade/Device Name: Proven Modular Tibial Tray Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 20, 2003

Dear Mr. Stevens:

Received: February 24, 2003

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

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Page 2 - Mr. Donald A. Stevens

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

Mark McMherm

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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510(K) Number (if known):

K030577

## Device Name: StelKast Proven Cemented, Semi-Constrained Total Knee System K980276 & K000113

## Indications For Use:

- 1. Total knee replacement due to 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.
- 3. For cemented use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

for

(Division Sign-Off)

Division of General Restorative

and Neurological Devices

| 510(k) Number | K030577 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR |
|----------------------|----------------------|
| (Per 21 CFR 801.109) | Over-The-Counter Use |

(Optional Format 1-2-96)