PROFEMUR XTR HIP STEM

K052915 · Wrightmedicaltechnologyinc · KWA · Jan 27, 2006 · Orthopedic

Device Facts

• Record ID: K052915
• Device Name: PROFEMUR XTR HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Jan 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROFEMUR® XTR Cemented Hip Stem 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 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - 2. inflammatory degenerative joint disease such as rhcumatoid arthritis; - 3. correction of functional deformity; and, revision procedures where other treatments or devices have failed 4.

Device Story

PROFEMUR® XTR Cemented Hip Stem is a femoral component for total hip arthroplasty; intended for cemented fixation only. Device features dual tapering stem and polished surface; available in 5 sizes. Designed for use with previously cleared WMT modular necks. Used by orthopedic surgeons in clinical settings to replace diseased hip joints; aims to reduce pain and improve hip function. Substantial equivalence established via comparison of intended use, materials, and design features to previously cleared devices.

Clinical Evidence

No clinical data provided; substantial equivalence supported by materials data and bench testing results.

Technological Characteristics

Cemented hip stem; dual tapering design; polished surface; available in 5 sizes; intended for use with modular necks. Materials and specifications not detailed beyond general classification as a metal/polymer semi-constrained cemented prosthesis.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), correction of 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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JAN 2.7 2006

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Sale 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 PROFEMUR® XTR Hip Stem.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 19, 2006 |
| Contact Person: | Theresa Leister Regulatory Affairs Specialist II |
| Proprietary Name: | PROFEMUR® XTR Cemented Hip Stem |
| Common Name: | Cemented Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer, semi- constrained, cemented prosthesis - Class II 21 CFR 888.3320 Hip joint metal/ metal semi- constrained, with a cemented acetabular component prosthesis -- Class III 21 CFR 888.3330 Hip joint metal/ metal semi- constrained, with an uncemented acetabular component prosthesis - Class III 21 CFR 888.3353 Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ JDI, LZO, JDL, KWA |

#### headquarters

Wright Medical Technology, Inc.

5677 Airline Road

Arlington TN 38002 901.867.9971 phone www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

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## DEVICE INFORMATION

### A. INTENDED USE

The PROFEMUR® XTR Cemented Hip Stem 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 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rhcumatoid arthritis;
- 3. correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.

## B. DEVICE DESCRIPTION

The design features of the PROFEMUR® XTR Cementcd Hip Stem are summarized bclow:

- The PROFEMUR® XTR Ccmented Hip Stem is available in 5 sizes and is intended . for use with previously cleared WMT modular necks.
- The PROFEMUR® XTR Cemented Hip Stem features a dual tapering stem and . polished surface.
- The PROFEMUR® XTR Ccmented Hip Stem is intended for cemented use only. .

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interfacc, and design features of the PROFEMUR® XTR Cemented Hip Stem are substantially equivalent to the devices previously cleared for market. The safety and effectiveness of the PROFEMUR® XTR Cemented Hip Stem are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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Public Health Service

JAN 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052915

> Trade/Device Name: Profemur XTR Cemented Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Regulatory Class: III Product Codes: KWA, JDL, LZO, JDI Dated: January 16, 2006 Received: January 18, 2006

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

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Page 2 – Ms. Theresa Leister

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. 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 N. Melkerson

ನ್ನಾ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# PROFEMUR® XTR Cemented Hip Stem INDICATIONS STATEMENT

KOSZ915 510(k) Number (if known):

Device Name: PROFEMUR® XTR Cemented Hip Stem

Indications For Use:

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The PROFEMUR® XTR Cemented Hip Stem 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 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis:
- correction of functional deformity; and, רי
- revision procedures where other treatments or devices have failed 4.

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)

MS

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

510(k) Number K082915