ADVANCE STATURE FEMORAL COMPONENT

K063731 · Wrightmedicaltechnologyinc · MBH · Mar 2, 2007 · Orthopedic

Device Facts

• Record ID: K063731
• Device Name: ADVANCE STATURE FEMORAL COMPONENT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBH · Orthopedic
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADVANCE STATURE™ Femoral Component is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The Porous ADVANCE STATURE™ Femoral Component is for use without bone cement. The Non-porous ADVANCE STATURE™ Femoral Component is for use with bone cement only. All ADVANCE STATURE™ Femoral Components are single use devices.

Device Story

ADVANCE STATURE™ Femoral Component is a cobalt chrome alloy knee prosthesis component. Available in porous (uncemented) and non-porous (cemented) versions in three sizes. Designed for use in knee arthroplasty to replace damaged joint surfaces, reduce pain, and restore function. Intended for use with existing tibial inserts. Single-use device implanted by orthopedic surgeons in a clinical/surgical setting. Provides structural replacement for femoral condyles to facilitate joint articulation.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design analysis and material information.

Technological Characteristics

Cobalt chrome alloy femoral component; available in porous and non-porous configurations; three size options; intended for use with compatible tibial inserts; single-use.

Indications for Use

Indicated for skeletally mature patients undergoing knee arthroplasty for pain relief or improved function due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, failed prior treatments, or unmanageable fractures.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Submission Summary (Full Text)

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K063731

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 0 2 2007

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 ADVANCE STATURE™ Femoral Component.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Date: | December 15, 2006 |
| Contact Person: | Theresa Leister |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | ADVANCE STATURE™ Femoral Component |
| Common Name: | Femoral Component |
| Classification Name and Reference: | 21 CFR 888.3565 Knee joint Patellofemorotibial<br>Metal/Polymer Porous-Coated Uncemented<br>Prosthesis - Class II |
| | 21 CFR 888.3560 Knee joint Patellofemorotibial<br>Polymer/Metal/Polymer Semi-Constrained<br>Cemented Prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ MBH, JWH |

#### DEVICE INFORMATION

#### A. INTENDED USE

The ADVANCE STATURE™ Femoral Component is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and
- 5) treatment of fractures that are unmanageable using other techniques.

The Porous ADVANCE STATURE™ Femoral Component is for use without bone cement.

The Non-porous ADVANCE STATURE™ Femoral Component is for use with bone cement only.

All ADVANCE STATURE™ Femoral Components are single use devices.

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### B. DEVICE DESCRIPTION

The design features of the ADVANCE STATURE™ Femoral Component are summarized below:

- Manufactured from Cobalt Chrome Alloy .
- Offered in porous and non porous versions .
- Offered in three sizes .
- Intended to be used with currently available tibial inserts ●

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and materials of the ADVANCE STATURE™ Femoral Component are identical to the predicate device. The design features of the ADVANCE STATURE™ Femoral Component are substantially equivalent to those of the predicate device. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the ADVANCE STATURE™ Femoral Component are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K063731

Trade Name: ADVANCE STATURE Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 8, 2007 Received: February 9, 2007

MAR 0 2 2007

Dear Ms. Leister:

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 your 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 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.

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Page 2 - Ms. Theresa Leister

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/industry/support/index.html.

Sincerely yours,
Mark A. Wilkerson

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

Enclosure

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63731

# Indications for Use

510(k) Number (if known):

Device Name: ADVANCE STATURE™ Femoral Component

Indications For Use:

The ADVANCE STATURE™ Femoral Component is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

- 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2.
- 3. correction of functional deformity;
- 4. revision procedures where other treatments or devices have failed; and
- 5. treatment of fractures that are unmanageable using other techniques.

The Porous ADVANCE STATURE™ Femoral Component is for use without bone cement. The Non-porous ADVANCE STATURE™ Femoral Component is for use with bone cement only.

All ADVANCE STATURE™ Femoral Components are single use devices.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

Mark N. Melkerson

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number K06373