Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. Inflammatory degenerative joint disease such as rheumatoid arthritis:
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and,
1. Treatment of fractures that are unmanageable using other techniques.

Device Description

The STEM is a modular prosthesis comprising two principal parts:

Zweymüller style rectangular distal stem and body .
. Modular neck
The STEM is available in nine sizes. All distal stems and bodies are rectangular in profile with a heavy grit blast surface finish. The STEM has a specific oblong housing/taper for the insertion of the twelve modular necks, which are available in six versions and two lengths: Neutral, antiversion 8° or 15°, varus/ valgus 8°, or combination of anteverted/ retroverted - varus/ valgus (in both short and long lengths).

AI/ML Overview

The provided document is a 510(k) Summary for the STEM Hip Replacement System, a medical device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific acceptance criteria and performance results directly from the device's own testing.

Therefore, many of the requested details about acceptance criteria, performance data, sample sizes, and expert adjudication are not available within this type of regulatory submission. A 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material data, design comparisons, and mechanical testing, rather than extensive clinical studies with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific quantitative clinical performance acceptance criteria for the new device as would be seen in a clinical trial report. The "performance" mentioned refers to the overall safety and effectiveness supported by substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/provided. This document describes a medical device seeking market clearance through the 510(k) pathway, which typically does not involve clinical testing on a "test set" of patient data in the way an AI diagnostic algorithm might. Instead, it relies on engineering testing, material data, and comparison to predicate devices. The "study" here is the 510(k) submission process itself, where the safety and effectiveness are established through demonstrating substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth establishment with experts is relevant for diagnostic devices that interpret images or other data. This is a hip replacement system, where ground truth would relate to surgical outcomes or pathology, which are not detailed as part of the 510(k) substantial equivalence argument in this document.

4. Adjudication Method for the Test Set

Not applicable. No "test set" in the context of diagnostic interpretation is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This is not an AI diagnostic algorithm, and no MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (hip implant), not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the conventional sense of a diagnostic algorithm. For a physical implant, "ground truth" would be clinical outcomes (reduction/relief of pain, improved hip function), pathology reports, or explant analysis, but none of these are presented as primary data in this summary. The "ground truth" for the 510(k) process is the safety and effectiveness of the predicate devices and the demonstration that the new device meets those same standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study (510(k) Submission) and its "Acceptance Criteria"

Acceptance Criteria (Implicit for 510(k)): The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to one or more legally marketed predicate devices. This means the device must be as safe and effective as the predicate(s). This is achieved by comparing:
- Intended Use
- Materials
- Design Features
- Type of interface (e.g., uncemented total hip arthroplasty)
- Performance data (e.g., mechanical testing, material characterization – though not explicitly detailed in this summary, it would be part of the full 510(k) submission).
Reported Device Performance (as per the submission):
- The "safety and effectiveness of the STEM Hip Replacement System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." (Section C. Substantial Equivalence Information)
- The FDA concluded that 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." (FDA Letter, Page 2)
- The device is indicated for reduction or relief of pain and/or improved hip function in skeletally mature patients with various degenerative joint conditions, inflammatory conditions, functional deformity, failed revision procedures, and unmanageable fractures.

In essence, the "study" is the 510(k) process itself, and the "acceptance criterion" is the FDA's determination of substantial equivalence based on the provided documentation, material testing, and comparison to existing, legally marketed devices.

Summary

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

W
WRIGHT
MEDICAL
TECHNOLOGY

JUL = 2 2002

K021346

A Wright Medical Group Company

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the STEM Hip Replacement System.

Submitted By:	Wright Medical Technology, Inc.
Date:	April 26, 2002
Contact Person:	Roger D. BrownDirector, Regulatory Affairs
Proprietary Name:	STEM Hip Replacement System
Common Name:	HIP REPLACEMENT SYSTEM
Classification Name and Reference:	21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented – Class II
Device Product Code and Panel Code:	Orthopedics/87/LPH

DEVICE INFORMATION

A. INTENDED USE

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. Inflammatory degenerative joint disease such as rheumatoid arthritis:
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and,
1. Treatment of fractures that are unmanageable using other techniques."

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The STEM Hip Replacement System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

B. DEVICE DESCRIPTION

The STEM is a modular prosthesis comprising two principal parts:

Zweymüller style rectangular distal stem and body .
. Modular neck

The STEM is available in nine sizes. All distal stems and bodies are rectangular in profile with a heavy grit blast surface finish. The STEM has a specific oblong housing/taper for the insertion of the twelve modular necks, which are available in six versions and two lengths: Neutral, antiversion 8° or 15°, varus/ valgus 8°, or combination of anteverted/ retroverted - varus/ valgus (in both short and long lengths).

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the STEM Hip Replacement System are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the STEM Hip Replacement System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Mr. Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K021346 Trade Name: STEM Hip Replacement System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 26, 2002 Received: April 29, 2002

Dear Mr. Brown:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Roger D. Brown

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the text "WRIGHT MEDICAL TECHNOLOGY" stacked in three lines on the right. A horizontal line is present below the text, and a registered trademark symbol is present to the right of the "W".

A Wright Medical Group Company

STEM HIP REPLACEMENT SYSTEM

INDICATIONS STATEMENT

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1) necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis; 2)
Correction of functional deformity; 3)
Revision procedures where other treatments or devices have failed; and, 4)
Treatment of fractures that are unmanageable using other techniques. ર)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use X (Per21 CFR 801.109)

Ov
(Op

(Division Sign-Off)

Over-The Counter Use (Optional Format 1-2-96)

510(k) Number K021346

Division of General, Restorative

and Neurological Devices

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.