SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS

K983733 · Sulzer Orthopedics, Inc. · JWH · Dec 18, 1998 · Orthopedic

Device Facts

• Record ID: K983733
• Device Name: SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The tibial baseplate stem plugs are intended use in the following diagnostic indications: - 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. - Those patients with failed previous surgery where pain, deformity, or 3. dysfunction persist. - Revision of previously failed knee arthroplasty. 4.

Device Story

Tibial baseplate stem plug; manufactured from wrought titanium alloy; designed to fit into female connection of tibial baseplate keel when no tibial stem component is used. Plug secured via small set screw; functions to restrict bone cement flow into baseplate. Used in orthopedic surgery for knee arthroplasty/revision. Device ensures proper cement containment during implantation; supports structural integrity of tibial baseplate assembly.

Clinical Evidence

Bench testing only; analysis indicated device survival under physiologic loading.

Technological Characteristics

Material: Wrought titanium alloy (ASTM F136). Form factor: Plug for tibial baseplate keel connection. Fixation: Set screw. Non-electronic, mechanical component.

Indications for Use

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

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

• Maxim Constrained Knee (Biomet)
• Coordinate Revision Knee (DePuy)
• Kinemax Plus Super Stabilizer (Howmedica)
• PFC - TC3 (Johnson and Johnson)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K-983733

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 Sulzer Orthopedics Apollo Constrained/Revision Knee Tibial Baseplate Stem Plugs.

| Submitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Date: | October 16, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC<br>Manager, Regulatory Affairs |
| Classification Name: | Prosthesis, knee, patellofemorotibial, semi-constrained,<br>cemented, polymer/ metal/polymer 21 CFR 888.3560 |
| Common/Usual Name: | Knee Prosthesis, Partially Constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Apollo Constrained/Revision Knee System<br>Tibial Baseplate Stem Plugs |

#### PRODUCT DESCRIPTION

The Sulzer Orthopedics Apollo Revision/Constrained Knee Tibial Baseplate Stem Plugs ("plug"), manufactured from wrought (ASTM F136) titanium alloy, are designed to fit into the female connection of the baseplate keel when no tibial stem component is used. The plug is connected to the baseplate component via a small set screw. The plugs therefore act to restrict the flow of bone cement into the baseplate component is intended for use with the Apollo Revision/Constrained Knee Tibial Baseplate.

### SPECIFIC DIAGNOSTIC INDICATIONS

The tibial baseplate stem plugs 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 Fluted Stems are substantially equivalent to stem plugs used with the Maxim Constrained Knee (Biomet), the Coordinate Revision Knee (DePuy), Kinemax Plus Super Stabilizer (Howmedica), and the PFC - TC3 (Johnson and Johnson).

Analysis indicated that the device would survive physiologic loading.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1998

Mitchell A. Dhority, RAC Manager, Regulatory Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

K983733 Re: Sulzer Orthopedics Apollo Trade Name: Constrained/Revision Knee System Tibial Baseplate Stem Pluqs Regulatory Class: II Product Code: JWH Dated: October 21, 1998 Received: October 22, 1998

Dear Mr. Dhority:

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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation 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 regulations.

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Page 2 - Mitchell A. Dhority, RAC

This letter will allow you to begin marketing your device as described in your 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 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 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): k983 733

Device Name: Apollo Revision/Constrained Knee System Tibial Baseplate Stem Plug

# Indications For Use:

The tibial baseplate stem plugs are intended 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).
- 2. Correctable valgus-varus deformity and moderate flexion contracture.
- 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)

holly

**Prescription Use** X

OR

Over-The-Counter Use

(Optional Format 1-2-96)