The CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell 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

Device Description

The design features of the CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
Porous coated with CoCrMo (ASTM F75) sintered beads with or without HA coating
Available sizes: 36mm-56mm ID
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
Flange with screw holes on the rim of the shell to enhance fixation
Cancellous flange screws available in 35-80 mm lengths

AI/ML Overview

The provided text is a 510(k) summary for the CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a Class III PMA (Premarket Approval) submission would.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Information Not Present: This document does not specify quantitative acceptance criteria or detailed performance metrics from a specific study. The basis for clearance is "substantial equivalence" to predicate devices, not performance against predefined clinical endpoints.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information Not Present: There is no mention of a "test set" in the context of a performance study for this device. The submission relies on equivalence to predicate devices and analysis data (likely mechanical/material testing, not clinical human trials for performance).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Information Not Present: No expert-established ground truth or clinical study data is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Present: No adjudication method is mentioned as there is no described test set or clinical study requiring such ground truth establishment.

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

Information Not Present: This device is an acetabular shell (a hip implant component), not an AI-driven diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

Information Not Present: As this is a medical implant, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information Not Present: Ground truth, in the context of clinical performance, is not discussed. The "ground truth" for a 510(k) is typically the performance and safety of the predicate device, which is considered legally marketed and safe/effective.

8. The sample size for the training set

Information Not Present: No "training set" in the context of an algorithm or AI model is applicable or mentioned.

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

Information Not Present: Irrelevant, as no training set or AI model is involved.

Summary of Device Information and Substantial Equivalence (from the text):

The CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell is demonstrated to be substantially equivalent to predicate devices. This means that its safety and effectiveness are considered comparable to devices already legally on the market.

Basis for Substantial Equivalence:
- Identical Indications for Use to predicate devices.
- Similar design features and materials to predicate devices.
- Fundamental scientific technology has not changed relative to predicate devices.
- Supported by material information and analysis data (likely mechanical, biocompatibility, etc., as per typical orthopedic implant testing, though specific tests/results are not detailed in this summary).

Key Takeaway: This document is a regulatory clearance through the 510(k) pathway, which fundamentally relies on demonstrating equivalence to existing devices. It does not typically involve the kind of detailed de novo clinical performance studies with acceptance criteria, ground truth, and reader studies that would be submitted for novel, high-risk devices or AI/imaging technologies.

Summary

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K060356

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 QUADRA-FIX™ Acetabular Shell.

Submitted By:	Wright Medical Technology, Inc.
Date:	March 14, 2006
Contact Person:	Matt Paul
	Regulatory Affairs Specialist
Proprietary Name:	CONSERVE® PLUS QUADRA-FIX™ AcetabularShell
Common Name:	Acetabular Shell
Classification Name and Reference:	21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabularcomponent prosthesis - Class III
	21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with cemented acetabular componentprosthesis - Class III
Device Product Code and Panel Code:	Orthopedics/87/KWA, JDL

DEVICE INFORMATION

A. INTENDED USE

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ﺎ . ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. correction of functional deformity; and,
revision procedures where other treatments or devices have failed 4.

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B. DEVICE DESCRIPTION

The design features of the CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell are summarized below:

. Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
. Porous coated with CoCrMo (ASTM F75) sintered beads with or without HA coating
Available sizes: 36mm-56mm ID
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
. Flange with screw holes on the rim of the shell to enhance fixation
Cancellous flange screws available in 35-80 mm lengths .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use of the CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell are identical to the predicate devices. The design features and materials of the CONSERVE® PLUS OUJADRA-FIX™ Acetabular Shell are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the CONSERVE® PLUS QUADRA-FIX™ Acctabular Shell are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES". The symbol in the center consists of three curved lines above two wavy lines.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2006

Wright Medical Technology, Inc. c/o Mr. Matt Paul Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K060356/S1

Trade/Device Name: CONSERVE® PLUS QUADRAFIX" Acetabular Shell Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, JDL Dated: March 17, 2006 Received: March 20, 2006

Dear Mr. Paul:

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 vour 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

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Page 2 - Mr. Matt Paul

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. 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 (240) 276-0120. 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 vours.

Herlin Lemirios

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

Enclosure

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K0603510

Indications for Use

510(k) Number (if known):

Dcvice Name:_CONSERVE® PLUS QUADRAFIX™ Acetabular Shell

Indications For Use:

The CONSERVE® PLUS QUADRAFIX™ Acetabular Shell is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in total in total in totally mature patients with the following conditions:

l ankylosis protrucio costsbuling joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and, 3.
1. revision procedures where other treatments or devices have failed

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Hukui Lerm

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K010035i

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.