CONSERVE BIO FOAM SHELL

K110029 · Wrightmedicaltechnologyinc · KWA · Apr 19, 2011 · Orthopedic

Device Facts

• Record ID: K110029
• Device Name: CONSERVE BIO FOAM SHELL
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Apr 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

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

Device Story

CONSERVE® BioFoam® Shell is a monoblock acetabular cup used in cementless total hip arthroplasty. Device is implanted by orthopedic surgeons in a clinical/hospital setting to address degenerative joint disease or functional deformity. It functions as a prosthetic component to replace the acetabulum, aiming to reduce pain and improve hip function. The device is available in 11 sizes and is constructed from CoCr alloy with a cpTi coating. It is a mechanical implant; no software or algorithms are involved.

Clinical Evidence

Bench testing only. Mechanical evaluation included frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. No clinical data provided.

Technological Characteristics

Monoblock acetabular cup available in 11 sizes. Materials: CoCr alloy with cpTi (commercially pure titanium) coating. Mechanical fixation (cementless).

Indications for Use

Indicated for skeletally mature patients requiring cementless total hip arthroplasty for: 1) non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia); 2) inflammatory degenerative joint disease (rheumatoid arthritis); 3) correction of functional deformity; 4) revision procedures where other treatments/devices failed.

Regulatory Classification

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).

Predicate Devices

• Metal TRANSCEND® Articulation System (K021349)
• CONSERVE® Plus Spiked Shells (K031963)
• 56mm DYNASTY® Acetabular System (K082924)

Submission Summary (Full Text)

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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.<br>5677 Airline Rd, Arlington TN, 38002<br>[phone] |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 31, 2010 |
| Contact Person: | Danielle Mueller<br>Regulatory Affairs Specialist II |
| Proprietary Name: | CONSERVE® BioFoam® Shell |
| Common Name: | Acetabular Cup |
| Classification Name and Reference: | 888.3330 Hip joint metal/metal semi-<br>constrained, with an uncemented acetabular<br>component prosthesis |
| Subject Product Code and Panel Code: | Orthopedics/87/KWA |
| Predicate Devices: | Metal TRANSCEND® Articulation System<br>CONSERVE® Plus Spiked Shells and 56mm<br>DYNASTY® Acetabular System<br>510(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;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed

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

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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

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.

## 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.

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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 [phone] or [phone] 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.
- 3. 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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