CONSERVE PLUS QUADRAFIX ACETABULAR SHELL

K060356 · Wrightmedicaltechnologyinc · KWA · Apr 18, 2006 · Orthopedic

Device Facts

• Record ID: K060356
• Device Name: CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Apr 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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 Story

The CONSERVE® PLUS QUADRA-FIX™ Acetabular Shell is a metal-on-metal acetabular component used in total hip arthroplasty. It is a one-piece shell designed to reconstruct the acetabulum while preserving bone stock to accommodate larger femoral heads. The device features a flange with screw holes for enhanced fixation and is used with cancellous flange screws. It is intended for use by orthopedic surgeons in a clinical/surgical setting. The device provides a stable articulating surface for the hip joint, aiming to reduce pain and improve function in patients with degenerative joint disease or those requiring revision surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by materials information and analysis data.

Technological Characteristics

Material: Cast cobalt-chromium-molybdenum (ASTM F75). Surface: Porous coated with CoCrMo sintered beads, optional HA coating. Dimensions: 36mm-56mm ID. Features: One-piece shell, flange with screw holes for fixation. Articulating surface: Superfinished. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, or revision procedures.

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).

Submission Summary (Full Text)

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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™ Acetabular<br>Shell |
| Common Name: | Acetabular Shell |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/ metal semi-<br>constrained, with an uncemented acetabular<br>component prosthesis - Class III |
| | 21 CFR 888.3320 Hip joint metal/ metal semi-<br>constrained, with cemented acetabular component<br>prosthesis - Class III |
| Device Product Code and Panel Code: | Orthopedics/87/KWA, JDL |

#### DEVICE INFORMATION

#### A. INTENDED USE

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, ﺎ . 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.

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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 [phone]. 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 [phone] or [phone] 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;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and, 3.
- 4. 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

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**510(k) Number** K010035i

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