The CONSERVE® BioFoam® 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

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® BioFoam® Shell is intended for cementless hip arthroplasty.

Device Description

Design features of the shells are summarized below:

. Monoblock acetabular cup
. Available in 11 sizes
. Manufactured from CoCr alloy with a cpTi coating

The CONSERVE® BioFoam® Shells were evaluated via mechanical testing; including frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. A review of these results indicates that the CONSERVE® BioFoam® Shells are equivalent to predicate devices.

AI/ML Overview

Here's the analysis of the acceptance criteria and study information for the CONSERVE® BioFoam® Shell, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence	The CONSERVE® BioFoam® Shells were evaluated via mechanical testing, including frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. A review of these results indicates that the CONSERVE® BioFoam® Shells are equivalent to predicate devices.
Substantial Equivalence (Indications for Use)	The indications for use of the CONSERVE® BioFoam® Shells are identical to the previously cleared predicate devices.
Design Features and Materials Equivalence	The design features and materials of the subject devices are substantially equivalent to those of the predicate devices.
Fundamental Scientific Technology Equivalence	The fundamental scientific technology of the modified devices has not changed relative to the predicate devices.

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the traditional sense of a clinical or image-based diagnostic study. The evaluation appears to be based on mechanical testing of the device itself, comparing its performance to predicate devices. Therefore, the "sample size" would refer to the number of devices or components tested. This information is not provided in the summary.
- Data Provenance: Not applicable in the context of this device's evaluation (it's a physical device, not an AI/diagnostic system using human data).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the evaluation described is for a physical medical device (an acetabular cup) through mechanical testing, not a diagnostic system requiring expert interpretation or ground truth establishment in a clinical setting.
Adjudication method for the test set:
- Not applicable for the type of evaluation described. Mechanical testing results are typically objective measurements, not subjective interpretations requiring adjudication.
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:
- No. This is a 510(k) submission for a physical orthopedic implant (acetabular cup), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" would be the objective, measured physical properties and performance characteristics (e.g., specific thresholds for frictional torque, bending fatigue limits, tensile strength, corrosion resistance, wear rates) that demonstrate the device's equivalence to the predicate devices. These are engineering specifications and material science standards rather than biological or clinical ground truth.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.

Summary of the Study and Findings:

The study described for the CONSERVE® BioFoam® Shell is a mechanical testing and substantial equivalence assessment (K110029). The purpose was to demonstrate that the new device is as safe and effective as existing legally marketed predicate devices.

The study primarily involved:

Mechanical Testing: Frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing were performed on the CONSERVE® BioFoam® Shells.
Comparison to Predicate Devices: The results from these mechanical tests were reviewed and used to demonstrate that the CONSERVE® BioFoam® Shells are equivalent to the identified predicate devices (Metal TRANSCEND® Articulation System, CONSERVE® Plus Spiked Shells, and DYNASTY® Acetabular System).
Substantial Equivalence Argument: The submission asserts that the new device's indications for use are identical, and its design features, materials, and fundamental scientific technology are substantially equivalent to the predicate devices.

The "study" in this context is an engineering and regulatory comparison, not a clinical trial or an AI performance evaluation. The "proof" that the device meets acceptance criteria lies in the successful demonstration of this equivalence through the aforementioned tests and comparisons.

Summary

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KI10029

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® BioFoam® Shell.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd, Arlington TN, 38002(800) 238-7188
Date:	December 31, 2010
Contact Person:	Danielle MuellerRegulatory Affairs Specialist II
Proprietary Name:	CONSERVE® BioFoam® Shell
Common Name:	Acetabular Cup
Classification Name and Reference:	888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent prosthesis
Subject Product Code and Panel Code:	Orthopedics/87/KWA
Predicate Devices:	Metal TRANSCEND® Articulation SystemCONSERVE® Plus Spiked Shells and 56mmDYNASTY® Acetabular System510(k)s: K021349, K031963, K082924

DEVICE INFORMATION

A. Intended Use

The CONSERVE® BioFoam® 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

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® BioFoam® Shell is intended for cementless hip arthroplasty.

Page 1 of 2

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K110027

B. Device Description

Design features of the shells are summarized below:

. Monoblock acetabular cup
. Available in 11 sizes
. Manufactured from CoCr alloy with a cpTi coating

C. Substantial Equivalence Information

The indications for use of the CONSERVE® BioFoam® 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® BioFoam® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

APR 1 9 2011

Wright Medical Technology, Inc. % Ms. Danielle Mueller Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K110029 Trade/Device Name: CONSERVE® BioFoam® Shells 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: December 31, 2010 Received: January 19, 2011

Dear Ms. Mueller:

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. Iisting 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

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Page 2 - Ms. Danielle Mueller

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 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/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

AS B. R

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): (( | | 0029

Device Name: CONSERVE® BioFoam® Shells

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.
1. correction of functional deformity; and,
revision procedures where other treatments or devices have failed. 4.

The CONSERVE® BioFoam® 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)

for M. Melleuson

(Division Sign-Of!) (Division Signical, Orthopedic, and Restorative Devices

510(k) Number K110029

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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.