PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT

K063211 · Stelkast Company · JWH · Jan 18, 2007 · Orthopedic

Device Facts

• Record ID: K063211
• Device Name: PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
• Applicant: Stelkast Company
• Product Code: JWH · Orthopedic
• Decision Date: Jan 18, 2007
• Decision: SESE
• Submission Type: Traditional
• 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 tissue integrity are present. For cemented use only.

Device Story

Proven Knee System High Flexion Tibial Insert is a prosthetic component for total knee arthroplasty. Device functions as a bearing surface within a semi-constrained cemented knee prosthesis system. Used by orthopedic surgeons in clinical settings to replace damaged joint surfaces. Provides high flexion capability to improve patient range of motion. Implanted via surgical procedure; requires bone cement for fixation. Benefits include restoration of joint function and mobility in patients with degenerative knee conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Material: Polymer tibial insert. Design: High flexion geometry. Fixation: Cemented. Regulatory Class II.

Indications for Use

Indicated for patients requiring total knee replacement or revision due to osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions, provided sufficient bone stock and soft tissue integrity exist. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stelkast Company % Mr. David J. Stumpo Vice President, Product Development 200 Hidden Valley Road McMurray, Pennsylvania 15317

JAN 1 8 2007

Re: K063211

Trade/Device Name: Proven Knee System High Flexion Tibial Insert 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: September 25, 2006

Received: October 23, 2006

Dear Mr. Stumpo:

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. David J. Stumpo

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/industry/support/index.html.

Sincerely vours,

Barbara Buell

Mark N. Melkerson 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):

Device Name: Proven Knee System High Flexion Tibial Insert

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 tissue integrity are present.
- 3. For cemented use only.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchus

(Division Sign-Of Division of General, Restorative, and Neurological Devices

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**510(k) Number** K063211