The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. 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.

The CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

Device Description

Design features of the shells are summarized below:

Monoblock acetabular cup .
. Available in 12 sizes
Manufactured from CoCr alloy with a CoCr porous bead coating .

The CONSERVE® Thin Shells are identical to previously cleared devices, except that the subject device does not possess HA coating. Additionally, the CONSERVE® Thin Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the CONSERVE® Thin Shells are equivalent to predicate devices.

AI/ML Overview

This document describes the CONSERVE® Thin Shell, an acetabular cup intended for use in cementless total hip arthroplasty. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than conducting a new clinical study with specific acceptance criteria and performance metrics for this particular device.

Here's an analysis of the provided information, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds for novel designs) that the CONSERVE® Thin Shell needed to meet to be cleared. This is typical for a 510(k) submission based on substantial equivalence, especially when the changes are minor.

Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is assessed by comparing the device's characteristics and functionality to those of already cleared devices.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
Identical Intended Use	The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients, which is identical to previously cleared predicate devices.
Substantially Equivalent Design Features	Design features include a monoblock acetabular cup, available in 12 sizes, manufactured from CoCr alloy with a CoCr porous bead coating. This is considered substantially equivalent to predicate devices, with the exception of the HA coating absence.
Substantially Equivalent Materials	The materials of the subject device are stated to be substantially equivalent to those of the predicate devices.
Fundamental Scientific Technology Unchanged	The fundamental scientific technology of the modified devices has not changed relative to the predicate devices.
Post-Impaction Analysis	Evaluated via post-impaction analysis of clearance, form, and frictional torque. A review of these results indicates equivalence to predicate devices.

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

The document does not describe a specific "test set" or a clinical study with human subjects for the CONSERVE® Thin Shell itself. The evaluation relied on bench testing and comparison to predicate devices.

Sample Size: Not applicable in the context of a human clinical test set. The "samples" would relate to the number of CONSERVE® Thin Shell units used for the post-impaction analysis. This specific number is not provided.
Data Provenance: Not applicable for human data. The "data" comes from engineering analysis and comparisons to existing device specifications.

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

This information is not applicable as there was no test set involving human subjects where expert ground truth was established by human readers/assessors. The "ground truth" here is derived from engineering standards, material science, and the established performance and safety profiles of the predicate devices as understood by the FDA and the manufacturer.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring multi-expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission establishes equivalence through design, materials, and bench testing, not through human reader performance studies.

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

Not applicable. This device is a physical medical implant, not an algorithm or software requiring performance evaluation in a standalone or human-in-the-loop context.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

Predicate device safety and effectiveness: The established performance and safety of the CONSERVE® HA Shells and CONSERVE® Acetabular Shell (TRANSCEND® Articulation System) serve as the benchmark.
Engineering specifications and material science: Compliance with recognized standards for materials (CoCr alloy) and design features is the basis for evaluation.
Bench testing data: Specifically, the post-impaction analysis of clearance, form, and frictional torque provided objective data to support the claims of equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. As there is no training set for this physical device.

In summary: The K113322 submission for the CONSERVE® Thin Shell relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This type of submission typically uses bench testing, material characterization, and comparison of design features and intended use to establish safety and effectiveness, rather than new clinical trials with acceptance criteria based on patient outcomes or expert reads. The key "study" mentioned is the "post-impaction analysis of clearance, form and frictional torque," which supported the claim that the device is equivalent to its predicates despite the absence of an HA coating.

Summary

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K113322

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2012

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 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the CONSERVE® Thin Shell.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd, Arlington TN, 38002(800) 238-7188
Date:	November 9, 2011
Contact Person:	Matt PaulProject Regulatory Affairs Specialist
Proprietary Name:	CONSERVE® Thin Shell
Common Name:	Acetabular Cup
Classification Name and Reference:	888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent prosthesisClass I
Subject Product Code and Panel Code:	Orthopedics/87/KWA
Predicate Devices:	CONSERVE® HA ShellsCONSERVE® Acetabular Shell (cleared as "MetalTRANSCEND® Articulation System")510(k)s: K042530, K021349

DEVICE INFORMATION

A. Intended Use

The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. 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.

The CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

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B. Device Description

Design features of the shells are summarized below:

Monoblock acetabular cup .
. Available in 12 sizes
Manufactured from CoCr alloy with a CoCr porous bead coating .

C. Substantial Equivalence Information

The indications for use of the CONSERVE® Thin Shells are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the CONSERVE® Thin Shells 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Incorporated % Mr. Matt Paul Project Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

FEB - 3 2012

Re: K113322

Trade/Device Name: CONSERVE® Thin Shell Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular Component, prosthesis Regulatory Class: Class III Product Code: KWA Dated: January 5, 2012 Received: January 6, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Eunel Keith

For Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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® Thin Shells

Intended Use:

The CONSERVE® Thin Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications For Use:

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; and, 3.
revision procedures where other treatments or devices have failed. 4.

The CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ollue
(Division Sign-Off)

ion of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113322

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.