The CONSERVE® Total Femoral Head is 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 necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed
The CONSERVE® Total Femoral Head is intended for single patient use only.

Device Description

Manufactured from wrought cobalt-chromium-molybdenum .
The articulating surface of the implants will be superfinished .
Available sizes: 36mm, 38mm, 42mm, 42mm, 46mm, 48mm, 50mm, 52mm, 52mm, . 54mm, 56mm
The taper connection is identical to previously cleared taper connections and is . intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for CONSERVE® Total Femoral Head

The acceptance criteria for the CONSERVE® Total Femoral Head are primarily focused on its wear performance compared to a predicate device, the Metal TRANSCEND® Femoral Head.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Marketing Claims)	Reported Device Performance (Wear Test Information)
Average of 10 times lower volumetric run-in wear rate than the Metal TRANSCEND® Femoral Head Bearings.	Not directly stated in a quantitative run-in wear rate, but overall volumetric wear is lower. (See below)
Average of 3.2 times lower cumulative volumetric wear than the Metal TRANSCEND® Femoral Head Bearings.	The average amount of volumetric wear at 5 million cycles for the test device (CONSERVE®) was 1.02mm³ less than that of the control device (Metal TRANSCEND®).

Note: The marketing claims present a ratio of improvement, while the reported performance provides a difference in absolute volumetric wear. The document implies that the 1.02 mm³ difference at 5 million cycles in favor of the CONSERVE® head is sufficient to meet the spirit of the acceptance criteria, particularly the cumulative volumetric wear claim. However, a precise calculation to verify the "3.2 times lower" claim based only on the 1.02mm³ difference and without knowing the absolute wear of the control device is not possible with the given information.

2. Sample Size and Data Provenance for the Test Set

Sample Size:
- The document states, "Both the test and control devices were 54mm diameter femoral heads." It also notes, "The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc." This phrasing suggests a limited number of devices were tested on these machines. While not explicitly stated, it's common for such in vitro wear tests to use a small number of samples (e.g., n=3 or n=6 for test and control groups) run in parallel on a simulator. The exact number of samples is not provided.
Data Provenance: The data is from in vitro hip wear simulator tests. The country of origin for the data is not specified, but the applicant (Wright Medical Technology, Inc.) is based in Arlington, Tennessee, USA, suggesting the testing was likely conducted in the USA. The study is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This is an in vitro mechanical wear test, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the objectively measured volumetric wear using established laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro mechanical test with objective measurements, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an imaging or diagnostic device. The study described is an in vitro mechanical wear test, not a clinical study involving human readers.

6. Standalone Performance Study

Yes, in a sense. The wear test described is a standalone in vitro performance study of the device itself (algorithm only, if one were to stretch the analogy, as it's purely mechanical performance). It measures the wear of the CONSERVE® Total Femoral Head and compares it directly to the Metal TRANSCEND® Femoral Head without human intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth used is objective quantitative measurement of volumetric wear obtained through controlled in vitro hip wear simulator tests. This is a form of engineering or laboratory "ground truth."

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The study focuses on direct mechanical performance testing.

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

Not applicable, as there is no training set for this type of device and study.

Summary

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K051348 (pg 1 of 3)

AUG ] 9 2005

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the 100d and in conformance with 21 CRF 807, this information serves as a Medical Devices 110 01 199 cities of the CONSERVE® Total Femoral Head.

Submitted By:	Wright Medical Technology, Inc.
Date:	August 3, 2005
Contact Person:	Theresa LeisterRegulatory Affairs Specialist
Proprietary Name:	CONSERVE® Total Femoral Head
Common Name:	Femoral Head
Classification Name and Reference:	21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular componentprosthesis - Class III21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabularcomponent prosthesis – Class III
Device Product Code and Panel Code:	Orthopedics/87/JDLOrthopedics/87/KWA

DEVICE INFORMATION

A. INTENDED USE

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; and,
1. revision procedures where other treatments or devices have failed

The CONSERVE® Total Femoral Head is intended for single patient use only.

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KCS1348 (pg 2 of 3)

B. DEVICE DESCRIPTION

Design Features

The design features of the CONSERVE® Total Femoral Head are summarized below:

Manufactured from wrought cobalt-chromium-molybdenum .
The articulating surface of the implants will be superfinished .
Available sizes: 36mm, 38mm, 42mm, 42mm, 46mm, 48mm, 50mm, 52mm, 52mm, . 54mm, 56mm
The taper connection is identical to previously cleared taper connections and is . intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

Wear Claims

The following marketing claims will be made for the CONSERVE® Total Femoral Head:

The articulation of the CONSERVE® Total Femoral Head Bearing has an average of . 10 times lower volumetric run-in wear rate than the currently available Metal TRANSCEND® Femoral Head Bearings. *
The articulation of the CONSERVE® Total Femoral Head Bearing has an average of . 3.2 times lower cumulative volumetric wear than the currently available Metal TRANSCEND® Femoral Head Bearings. *

* Wear Test Information

(a) The CONSERVE® Total Femoral Head and the Metal TRANSCEND® Femoral Head are manufactured by Wright Medical Technology, Inc.
(b) The test device was the CONSERVE® Total Femoral Head and the control device was the Metal TRANSCEND® Femoral Head
(c) Both the test and control devices were 54mm diameter femoral heads.
(d) The articulating surface of both the test and control device was mirror finished.
(e) The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc.
(f) Both the test and control devices were tested for 5 million cycles.
(g) The material of the device was a CoCr alloy and the bearing size was 54mm.
(h) The lubricant used was 90% alpha calf serum with 0.2% sodium azide, 20mM EDTA and distilled water.
(i) The average amount of volumetric wear at 5 million cycles for the test device was 1.02mm3 less than that of the control device.
(j) Both the test and control devices were sterilized.
(k) The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

Image /page/1/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

Image /page/1/Picture/26 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The drawing is simple and has a vintage look.

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Special 510(k)
CONSERVE® Total Femoral Head
510(K) SUMMARY
Page 3 of 3

K051348(pg 3 of 3)

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use and type of interface of the CONSERVE® Total Femoral Head are The intended use and type of internation Femoral Heads (Larger Sizes). The design features and material are substantially equivalent to the Metal TRANSCEND® Femoral Heads (Larger Sizes). The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, and testing results, provided within the Premarket Notification.

Image /page/2/Picture/4 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents are visible on the globe, but they are not labeled. The globe is surrounded by a ring, which may represent the equator or another line of latitude. The image is simple and straightforward, and it is likely intended to be used for educational purposes.

510(K) SUMMARY- Amended 8-3-05

WRIGHT
MEDICAL TECHNOLOGY, INC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

AUG 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. . . . . . 5677 Airline Road Arlington, Tennessee 38002

Re: K051348

Trade/Device Name: NSERVE® Total Femoral Head Regulation Number: 21CFR 888.3320, 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component prosthesis, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III

Product Code: JDL, KWA Dated: August 1, 2005 Received: August 2, 2005

Dear Ms. Leister:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bedeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered processions) in accordance with the provisions of the Federal Food, Drug, de necs mat nave been require approval of a premarket approval application (PMA). and Cosmetic Prov (110) market the device, subject to the general controls provisions of the Act. The I va mayy are or visions of the Act include requirements for annual registration, listing of general controls profice, 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 rr your device is elabilition (tional 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 than v 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 – Ms. Theresa Leister

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manxoting your and equivalence of your device to a legally premarket nothleadon: The PDA midning of castification 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), please If you desire specific acvice for your accel (240) 276-0210. Also, please note the regulation entitled, comact the Office of Compullion in (21 CFR Part 807.97). You may obtain Misblanding by reference to premaintonions in the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolbanhoon of the world the more of the many of the states html.

Sincerely yours,

Z
Michael W. Mollen

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: CONSERVE® Total Femoral Head

Indications For Use:

The CONSERVE® Total Femoral Head is indicated for use in total hip arthroplasty for reduction The CONSERVE® Total Fead is marcally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
allkylosis, protrasto accuse joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. conceedures where other treatments or devices have failed

The CONSERVE® Total Femoral Head is intended for single patient use only.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

2-1 - 1 - 1 - - -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051348

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.