NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS

K983153 · Sulzer Orthopedics, Inc. · JWH · Dec 4, 1998 · Orthopedic

Device Facts

• Record ID: K983153
• Device Name: NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Natural-Knee II P.S. Condylar Tibial Inserts are intended for use in the following diagnostic indications: 1. Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis). 2. Correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity, or dysfunction persist. 4. Revision of previously failed knee arthroplasty.

Device Story

The Natural-Knee II P.S. Condylar Tibial Insert is a prosthetic component for total knee arthroplasty. It is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPe). The device is designed as an asymmetric insert available in left/right orientations, multiple sizes, and thicknesses. It functions as part of the Natural-Knee II system, specifically intended for use with the Natural-Knee II Constrained Femoral Component and compatible tibial baseplates. The device is implanted by an orthopedic surgeon in a clinical setting. It is strictly indicated for cemented fixation to replace damaged joint surfaces, aiming to restore joint function, reduce pain, and correct deformities in patients with degenerative joint disease or failed prior surgeries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ultra High Molecular Weight Polyethylene (UHMWPe) conforming to ASTM F648. Design: Asymmetric tibial insert, available in 3 sizes and 7 thicknesses (9-25mm). Minimum polyethylene thickness under condyles is 6.00 mm for the 9mm insert. Fixation: Cemented only. Sterilization: Not specified.

Indications for Use

Indicated for patients with inflammatory degenerative joint disease (e.g., rheumatoid arthritis), noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis), correctable valgus-varus deformity, moderate flexion contracture, or those requiring revision of failed previous knee arthroplasty. Intended 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

• Natural-Knee® II Constrained Knee Tibial Inserts
• Natural-Knee® II P.S. Tibial Inserts
• Apollo™ Constrained/Revision Knee Tibial Inserts

Submission Summary (Full Text)

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# 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Natural-Knee II Posterior Stabilized Condylar Insert.

| Submitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Date: | August 25, 1998 |
| Contact Person: | Mitchell Dhority, RAC<br>Manager, Regulatory Affairs |
| Classification Name: | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,<br>polymer/ metal/polymer 21 CFR 888.3560 |
| Common/Usual Name: | Knee Prosthesis, Partially Constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Natural-Knee® II Posterior Stabilized (P.S.)<br>Condylar Tibial Inserts |

### PRODUCT DESCRIPTION

The Sulzer Orthopedics P.S. Condylar Tibial Inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHWMPe) conforming to ASTM F648. The Condylar Inserts are asymmetric; therefore they are available in left and right orientations. The inserts are available in three sizes 00/0, 1/2, and 3/4/5) and seven thicknessses (9, 11, 13, 16, 19, 22, and 25). This device is intended for use with the following devices:

- Natural-Knee® II Constrained Femoral Component. These tibial inserts cannot be used with any other femoral components
- . Natural-Knee® II Constrained Knee Tibial Baseplate
- Natural-Knee® II System Tibial Baseplate.

### SPECIFIC DIAGNOSTIC INDICATIONS

The Sulzer Orthopedics P.S. Condylar Tibial Inserts are intended for cemented use in the following diagnostic indications:

- 1) Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
- 2) Correctable valgus-varus deformity and moderate flexion contracture.
- 3) Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
- 4) Revision of previously failed knee arthroplasty.

### SUBSTANTIAL EQUIVALENCE

The Sulzer Orthopedics P.S. Condylar Tibial Inserts are substantially equivalent to the following: the Natural-Knee® II Constrained Knee Tibial Inserts, the Natural-Knee® II P.S. Tibial Inserts, and the Apollo" Constrained/Revision Knee Tibial Inserts.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a bird in flight, composed of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 DEC

> Ms. Denise Duchene Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

K983153 Re: Sulzer Orthopedics Natural-Knee® II Posterior Stabilized (P.S.) Condylar Tibial Inserts Regulatory Class: II Product Code: JWH Dated: September 8, 1998 Received: September 9, 1998

Dear Ms. Duchene:

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 "9 1. mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.00 mm.
- 2. This device may not be labeled or promoted for noncemented use.
- 3. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
- 4 . Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under

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21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

The general controls provisions of the Act include requirements for annual registration, 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. ಗಿ 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 In addition, FDA may publish further announcements action. 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 labeling 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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obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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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510(k) Number (if known):

Device Name: Natural-Knee® II Posterior Stabilized (P.S.) Condylar Tibial Inserts

## Indications For Use:

The Natural-Knee II P.S. Condylar Tibial Inserts are intended for use in the following diagnostic indications:

- Patient conditions, including but not limited to, inflammatory degenerative joint 1. disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
- Correctable valgus-varus deformity and moderate flexion contracture. 2.
- Those patients with failed previous surgery where pain, deformity, or 3. dysfunction persist.
- Revision of previously failed knee arthroplasty. 4.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <hr/> </div> |
|------------------|--------------------|
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OR

| Over-The-Counter Use | <div> <hr/> </div> | (Optional Format 1-2-96) |
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| | (Division Sign-Off) Division of General Restorative Devices | |
| 510(k) Number | 1983153 | |