The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are 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 theumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.

Device Description

The design features of the CONSERVE® Plus Spiked Shell are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
Porous coated with CoCrMo (ASTM F75) Sintered beads
Available sizes: 36mm-56mm ID; available in two shell thicknesses 3.5mm and 4.5mm
The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head
Spikes are added to the outer surface to enhance fixation .

The design features of the CONSERVE® Total 56mm Femoral Head are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
Available size: 56mm
Available neck lengths: -3.5, 0, +3.5
The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
The taper connection for the CONSERVE® Total 56mm Femoral Head will be identical to the Metal TRANSCEND® Femoral Heads Larger Sizes and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head) seeking substantial equivalence to a legally marketed predicate device.

Here's why the requested information cannot be extracted from the provided text:

Acceptance Criteria and Reported Device Performance: This document describes the device's design features, intended use, and states that its safety and effectiveness are supported by "substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification." However, it does not explicitly list any acceptance criteria (e.g., performance metrics, thresholds) or report specific device performance results against such criteria. The focus is on demonstrating similarity to a predicate device, not on presenting novel performance data against predefined metrics.
Sample Size for Test Set and Data Provenance: No details about a specific "test set" are provided. While "testing results" and "clinical data" are mentioned as supporting evidence, the document does not specify the nature of these tests, the sample sizes, or the origin of any data (e.g., country, retrospective/prospective).
Number of Experts, Qualifications, and Adjudication Method: Since there's no description of a study involving ground truth establishment, there is no mention of experts, their qualifications, or adjudication methods.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The device described is a physical orthopedic implant, not an AI-powered diagnostic tool.
Standalone Performance: While the device itself is a standalone implant, the concept of "standalone performance" for an algorithm (without human-in-the-loop) does not apply here as it is not an AI-based device. If it refers to the implant's mechanical performance, specific test results are not detailed.
Type of Ground Truth: No specific ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned because the document is not detailing a study that relies on such methods for performance evaluation. The substantial equivalence argument relies on similarity to existing devices and general material/design validation.
Sample Size for Training Set and How Ground Truth for Training Set Was Established: This information is entirely irrelevant and not present, as the device is a physical implant and not an AI model that would require a "training set."

In summary, the provided K031963 document is a 510(k) summary for a hip replacement component. It focuses on device description, intended use, and claims of substantial equivalence to predicate devices based on materials and design, rather than detailing a rigorous performance study with specific acceptance criteria and outcome measurements as might be found for a diagnostic or AI-powered medical device.

Summary

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Ko31963 p.1/2

OCT 3 1 2003

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 CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head.

Submitted Bv:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

June 23, 2003

Katie Logerot Regulatory Affairs Associate

CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head

Spiked Acetabular Shell and Femoral Head

21 CFR 888.3320 Hip joint metal/ metal semiconstrained, with a cemented acetabular component prosthesis - Class III

21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III

Device Product Code and Panel Code:

Orthopedics/87/KWA

Orthopedics/87/JDL

DEVICE INFORMATION

A. INTENDED USE

The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Fernoral Head are 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;
inflammatory degenerative joint disease such as theumatoid arthritis; 2.
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901,867.9971 phone www.wmt.com

International subsidiaries 011,32,2,378.3905 Belglum 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

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KO31963

The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.

B. DEVICE DESCRIPTION

The design features of the CONSERVE® Plus Spiked Shell are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
Porous coated with CoCrMo (ASTM F75) Sintered beads
Available sizes: 36mm-56mm ID; available in two shell thicknesses 3.5mm and ● 4.5mm
. The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while ● removing very little bone to accommodate a larger Femoral Head
Spikes are added to the outer surface to enhance fixation .

The design features of the CONSERVE® Total 56mm Femoral Head are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 ●
Available size: 56mm .
Available neck lengths: -3.5, 0, +3.5 ●
The articulating surface of the implants will be superfinished to insure form tolerance ● and a fine surface finish
The taper connection for the CONSERVE® Total 56mm Femoral Head will be . identical to the Metal TRANSCEND® Femoral Heads Larger Sizes and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, and type of interface of the CONSERVE® Plus Spiked Shells are identical to the Metal TRANSCEND® Articulation Monoblock Shell. The design features are identical with the exception of additional spikes, a thinner wall, and a larger size offering. The CONSERVE® Total 56mm Femoral Head is a size addition to the Metal TRANSCEND® Femoral Head (Larger Sizes). The design features of the CONSERVE® Total 56mm Femoral Head are identical to the design features of the Metal TRANSCEND® Femoral Head (Larger Sizes). The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification.

Image /page/1/Picture/19 description: The image shows a black and white graphic that appears to be a partial view of a globe or planet. The upper portion of the image features a textured, circular shape, possibly representing land or geographical features. A curved line is visible above the circular shape, suggesting an atmospheric layer or the edge of the planet. At the bottom of the image, there is some illegible text, which seems to be a label or caption associated with the graphic.

Image /page/1/Picture/20 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 the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, underlined by a thin line.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2003

Ms. Katie Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002

Re: K031963

Trade/Device Name: CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head

Regulation Number: 21 CFR 888.3320 and 888.3330

Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis

Regulatory Class: III Product Code: KWA and JDL Dated: September 30, 2003 Received: October 1, 2003

Dear Ms. Logerot:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 - Ms. Katie Logerot

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark N. Mulkerson

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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K031963

Image /page/4/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of three stylized, overlapping shapes that resemble wings or feathers. The letters are large and spaced closely together, creating a strong visual impact. The graphic element adds a sense of movement and dynamism to the logo.

CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head

INDICATIONS STATEMENT

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® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per21 CFR 801.109) OR

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

Division of General Restorative Devices

R. Mark N. Milken

eral. Rest rative ical Devices

510(k) Number _

K031963

(Division Sign-Off)

510(k) Number

headquarters Wright Medical Technology, Inc.

5677 Airline Road Arlington, TN 36002 901.867.9971 phone www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905,826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented 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. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without 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 an uncemented 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 an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.