GEM INSET PATELLAR COMPONENT

K032950 · Kinamed, Inc. · JWH · Dec 19, 2003 · Orthopedic

Device Facts

• Record ID: K032950
• Device Name: GEM INSET PATELLAR COMPONENT
• Applicant: Kinamed, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gem™ Inset Patellar Component is intended to articulate with the Gem™ Total Knee femoral component or the KineMatch™ Patello-Femoral Resurfacing Implant. The Gem" Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem " Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

Device Story

Gem™ Inset Patellar Component is a prosthetic implant designed for knee arthroplasty. It functions as a replacement for the patellar articulating surface, articulating with the Gem™ Total Knee femoral component or KineMatch™ Patello-Femoral Resurfacing Implant. The device is intended for single-use, cemented application on the surgically prepared posterior patella. It is used by orthopedic surgeons in a clinical/surgical setting to restore normal knee function during primary or revision procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Patellar component for cemented knee arthroplasty. Materials include polymer/metal/polymer construction. Semiconstrained design. Single-use.

Indications for Use

Indicated for patients undergoing primary or revision knee arthroplasty requiring replacement of the patellar articulating surface. Intended for cemented application on the surgically prepared posterior patella.

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).

Reference Devices

• Gem™ Total Knee femoral component
• KineMatch™ Patello-Femoral Resurfacing Implant

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Vineet Sarin, Ph.D. Director of Research and Development Kinamed, Inc. 820 Flynn Road Camarillo, California 93012-8701

Rc: K032950 Trade/Device Name: Gem™ Inset Patellar Component Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: September 19, 2003 Received: September 22, 2003

Dear Dr. Sarin:

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 -- Vineet Sarin, Ph.D.

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/dsma/dsmamain.html

Sincerely yours,

Mark N. Millkens

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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## Statement of Indications for Use

510(k) Number (if known): K032950

## Device Name: Gem™ Inset Patellar Component

Indications for Use:

The Gem™ Inset Patellar Component is intended to articulate with the Gem™ Total Knee femoral component or the KineMatch™ Patello-Femoral Resurfacing Implant. The Gem" Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem " Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

OR Over-the-Counter Use

Mark N. Millerson