PRECEDENT REVISION HIP SYSTEM

K972637 · Sulzer Orthopedics, Inc. · LZO · Oct 1, 1997 · Orthopedic

Device Facts

• Record ID: K972637
• Device Name: PRECEDENT REVISION HIP SYSTEM
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The general indications associated with the use of the Precedent Revision Hip system without HA in total hip arthroplasty include: - Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis. - Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists. - 3. Revision of previously failed arthroplasty. The Precedent Revision Hip System without HA is intended only for use without bone cement.

Device Story

Femoral hip prosthesis for revision arthroplasty; manufactured from wrought or forged titanium alloy. Features threaded 12/14 neck trunnion for modular head attachment; grit-blasted surface for fixation; distal flutes for rotational stability; coronal slot to reduce bending stiffness. Used in orthopedic surgery; implanted by surgeons. Device provides structural replacement for femoral bone deficiencies; intended for cementless fixation. Benefits include restoration of hip mobility and reduction of pain/dysfunction in patients with failed primary arthroplasties.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Wrought or forged titanium alloy. Design: Modular femoral stem with 12/14 neck trunnion, grit-blasted surface, distal flutes, and coronal slot. Fixation: Cementless. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or revision of failed hip arthroplasty. Intended for cementless application in total or hemi-hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Sentry Femoral Component (Howmedica Inc.)
• S-ROM® Femoral Prosthesis (Joint Medical Product Corporation)
• Stability Hip Stem (Depuy Inc.)
• Wagner Revision Stem (Protek Inc.)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K972637

। రచ

OCT - 1 1997

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 Precedent Revision Hip System without HA.

| Submitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date: | July 14, 1997 |
| Contact Person: | Jacquelyn Hughes<br>Manager, Regulatory Affairs |
| Classification Name: | Hip Joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis - 21CFR 888.3353 (87LZO). |
| Common/Usual Name: | Femoral hip prosthesis |
| Trade/Proprietary Name: | Precedent Revision Hip System |

## PRODUCT DESCRIPTION

The Precedent Revision Hip System is manufactured from either wrought or forged titanium alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.

This device is intended for use with the following previously cleared devices:

- Sulzer Orthopedics metallic femoral bearing heads 체
- Sulzer Orthopedics Biolox Bearing Heads I
- 트 Sulzer Orthopedics Zirconia Bearing Heads
- Sulzer Orthopedics bipolar components
- Sulzer Orthopedics unipolar components
- 제 Sulzer Orthopedics acetabular components

{1}------------------------------------------------

972637
2 of 2

## SPECIFIC DIAGNOSTIC INDICATIONS

Precedent Revision Hip System is primarily intended to address femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties. In addition, the Precedent Revision Hip System, like the predicate competitive hip stems, is intended for cementless application.

The general indications associated with the use of the Precedent Revision Hip System in total hip arthroplasty include:

- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- 3. Revision of previously failed hip arthroplasty

Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple ioint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

The Precedent Revision Hip System is intended only for use without bone cement in the United States. This device is intended for single use only.

### SUBSTANTIAL EQUIVALENCE

The Precedent Revision Hip System is substantially equivalent to the following legally marketed predicate competitive devices:

- 제 Sentry Femoral Component: Howmedica Inc.
- . S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
- Stability Hip Stem: Depuy Inc.
- 피 Wagner Revision Stem: Protek Inc.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 -

Lori K. Holder, RAC Requlatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

K972637 Re: Precedent Revision Hip System Trade Name: (Grit Blasted) Regulatory Class: II Product Code: LZO Dated: July 14, 1997 Received: July 15, 1997

Dear Ms. Holder:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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. Please note: concerning your device in the Federal Register. 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.

{3}------------------------------------------------

### Page 2 - Lori K. Holder, 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 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,

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

{4}------------------------------------------------

510(k) Number (if known): 1972637

Device Name: Precedent Revision Hip System without HA

# Indications For Use:

The general indications associated with the use of the Precedent Revision Hip system without HA in total hip arthroplasty include:

- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
- 3. Revision of previously failed arthroplasty.

The Precedent Revision Hip System without HA is intended only for use without bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

\$\int_{}^{}\$coello

(Division Sign-Off) Division of General Restorative I 510(k) Number

**Prescription Use** X

OR

Over-The-Counter Use _

(Optional Format 1-2-96)