Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed arthroplasty.
The Precedent Revision Hip System without HA is intended only for use without bone cement.

Device 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.

AI/ML Overview

This document is a 510(k) summary for the Precedent Revision Hip System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or stated based on the document's content:

1. Table of acceptance criteria and reported device performance:

This document does not specify quantitative acceptance criteria or report specific performance metrics from a dedicated study. The focus is on demonstrating "substantial equivalence" to existing legally marketed devices, implying that its performance is considered acceptable if it is similar to those predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample size used for the test set and the data provenance:

No test set or associated data provenance is mentioned as this is a 510(k) for substantial equivalence, not a performance study as typically understood for new algorithms or AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a hip implant, not an AI-assisted diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hip implant, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" here is the long-standing clinical experience and performance of the predicate hip systems, which the Precedent Revision Hip System is attempting to be substantially equivalent to.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/algorithm development.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what the document does provide:

Device: Precedent Revision Hip System, a femoral hip prosthesis for revision total hip arthroplasty.
Purpose of filing: 510(k) to demonstrate substantial equivalence to predicate devices.
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.
Indications for Use: Primarily for femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties, and for cementless application in total hip arthroplasty for conditions like non-inflammatory degenerative joint disease, inflammatory joint disease, and revision of previously failed arthroplasty.
Regulatory Conclusion: The FDA determined the device is substantially equivalent to marketed devices prior to May 28, 1976. This allows marketing subject to general controls provisions of the Act.

Summary

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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.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900
Date:	July 14, 1997
Contact Person:	Jacquelyn HughesManager, Regulatory Affairs
Classification Name:	Hip Joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis - 21CFR 888.3353 (87LZO).
Common/Usual Name:	Femoral hip prosthesis
Trade/Proprietary Name:	Precedent Revision Hip System

PRODUCT DESCRIPTION

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

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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.
1. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
1. 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.

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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.

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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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): 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.
1. 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)

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

Prescription Use X

Over-The-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.