FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM

K992287 · Howmedica Osteonics Corp. · HSX · Nov 16, 1999 · Orthopedic

Device Facts

• Record ID: K992287
• Device Name: FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSX · Orthopedic
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The First Step Unicompartmental Knee System consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to be used to replace the medial or lateral compartments of the knee joint, specifically the femorotibial joint damaged as a result of inflammatory and non-inflammatory joint disease or trauma. These components are intended for cemented use only.

Device Story

System comprises distal femoral and proximal tibial resurfacing components; intended for cemented replacement of medial or lateral knee compartments. Used in orthopedic surgery to treat joint disease or trauma. Components implanted by surgeons to restore joint function and alleviate pain. Benefits include joint resurfacing for patients with unicompartmental arthritis or failed prior procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Femoral component: cobalt-chromium alloy (ASTM F-75). Tibial component: ultra-high molecular weight polyethylene (ASTM F-648). Cemented fixation. Single-use, sterile.

Indications for Use

Indicated for patients with moderately disabling knee joint disease due to painful osteo- or post-traumatic arthritis, revision of previous unsuccessful unicompartmental knee replacement or other procedures, and as an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Duracon Unicompartmental Knee
• SCR Uni Knee Systems

Submission Summary (Full Text)

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## First Step Unicompartmental Knee System

510(k) Summary

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## 510(k) Summary

| Device: | First Step Unicompartmental Knee |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Unicompartmental Knee System |
| Classification Name: | Knee joint femorotibial metal/ polymer non-constrained cemented<br>prosthesis 21 CFR §.888.3520 |
| Regulatory Class: | Class II |
| Product Code: | 87 HSX |
| For Information contact: | Karen Ariemma, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>[phone]<br>Fax: [phone] |

This device consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to be used to replace the medial or lateral compartments of the knee joint, specifically the femorotibial joint damaged as a result of inflammatory and non-inflammatory joint disease or trauma. These components are intended for cemented use only. The femoral component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-75. The tibial component is manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648.

The substantial equivalence of this device is based on equivalence in intended use, materials, design and operational principles to other predicate devices indicated for unicompartmental knee surgery. These devices include Howmedica Osteonics Corp.'s Duracon Unicompartmental Knee and SCR Uni Knee Systems.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1999

Ms. Terry Sheridan Powell Requlatory Affairs Team Stryker Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K992287 First Step Unicompartmental Knee System Trade Name: Regulatory Class: II Product Code: HSX September 13, 1999 Dated: Received: September 17, 1999

Dear Ms. Powell:

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 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 (Premarket Approval), 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 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 requlation (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.

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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 regulation (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,

James E. Dillard III Acting 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): K 99 JJK 7

Device Name: Howmedica Osteonics® First Step Unicompartmental Knee System

The First Step Unicompartmental Knee System consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. The subject components of the First Step Unicompartmental Knee System are single use devices which are sold sterile. The First Step Unicompartmental Knee System is intended for cemented use only.

The specific indications and contraindications of the First Step Unicompartmental Knee System are stated in the following sections.

Indications

- Moderately disabling joint disease of the knee resulting from painful osteo- or post ● traumatic arthritis.
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use X OR

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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