ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT

K980999 · Instrument Makar, Inc. · JWH · Nov 6, 1998 · Orthopedic

Device Facts

• Record ID: K980999
• Device Name: ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
• Applicant: Instrument Makar, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not parted to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.

Device Story

St. Leger Total Knee Implant is a prosthetic device designed for surgical replacement of the knee joint. It addresses pain and physical deformities resulting from degenerative, traumatic, inflammatory, or rheumatoid arthritis. The device is intended for use in primary or revision knee arthroplasty. It must be fixed within the bone using acrylic bone cement; non-cemented fixation is prohibited. The device features a tibial insert with a minimum polyethylene thickness of 7.00mm under the condyles. It is intended for prescription use by orthopedic surgeons in a clinical/hospital setting. The implant aims to restore joint function, reduce pain, and improve patient mobility and ability to perform daily activities.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use characteristics.

Technological Characteristics

Total knee prosthesis; includes a tibial insert with a minimum polyethylene thickness of 7.00mm under the condyles. Requires fixation with acrylic bone cement. No other specific materials or technical specifications provided.

Indications for Use

Indicated for patients with knee joint pain and/or deformity, including severe degenerative, traumatic, inflammatory, or rheumatoid arthritis. Applicable for revision surgery due to loosening, infection, or prior implant failure, provided anatomical conditions allow for acceptable alignment and fixation.

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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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top and left side of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOW

Lanny L. Johnson, M.D. Instrument Makar, Inc. 2950 East Mount Hope Road Okemos, Michigan 48864

Re : K980999 St. Leger Total Knee Implant Trade Name: Regulatory Class: II Product Code: JWH Dated: August 6, 1998 Received: August 10, 1998

Dear Dr. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your device subject to cement . " the general controls provisions of the Act and the following limitations:

- The thinnest tibial insert available is the nominal "7mm" 1. sized insert, which has a minimum polyethylene thickness under the condyles of 7.00mm.
- This device may not be labeled or promoted for non-2. cemented use.
- All labeling for this device, including package label 3. and labeling included within the package, must prominently state that the device is intended for cemented use only.
- Any non-cemented fixation of this device is considered 4 . investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their

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respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investiqation.

The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Lanny L. Johnson, M.D.

obtained from the Division of Small Manufacturers Assistance obcarned from che bring(800) 638-2041 or [phone] or at at Its Coll":rec namber (000) 050fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D., M.D.
Director
Division of General and

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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002

510(k) Number (if known): __ K 980999

ST LEGER TOTAL KNEE Device Name:

## Indications For Use:

The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not parted to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)-.

(Division Sign-Off)

sion of General Restorative Devices

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)