PROFEMUR TAPERED HIP STEM

K041114 · Wrightmedicaltechnologyinc · JDL · May 28, 2004 · Orthopedic

Device Facts

• Record ID: K041114
• Device Name: PROFEMUR TAPERED HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JDL · Orthopedic
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3320
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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

Device Story

PROFEMUR® Tapered Hip Stem is a modular hip prosthesis used in total hip arthroplasty. Device features include a modular neck taper, tapered cylindrical distal stem, plasma-sprayed proximal body, grit-blasted distal stem, polished bullet tip, and spines. Implanted by orthopedic surgeons in a clinical/hospital setting to replace diseased or damaged hip joints. Provides structural support and articulation for the hip joint; aims to reduce pain and restore function in patients with degenerative joint disease or failed previous implants.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material analysis.

Technological Characteristics

Modular hip prosthesis featuring a modular neck taper, tapered cylindrical distal stem, plasma-sprayed proximal body, grit-blasted distal stem, and polished bullet tip. Materials and design are consistent with established hip arthroplasty systems.

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 failed prior procedures.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with a cemented 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. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• PROFEMUR® Z Hip Stem
• PERFECTA® RS Hip Stem
• PERFECTA® Plasma Sprayed Hip Stem

Submission Summary (Full Text)

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K04/1114

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MAY 2 8 2004

## 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 PROFEMUR® Tapered Hip Stem.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | April 26, 2004 |
| Contact Person: | Katie Logerot |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | PROFEMUR® Tapered Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Class II |
| | 21CFR 888.3350 Hip joint metal/polymer, semi-constrained, cemented prosthesis - Class II |
| | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented – 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 |
| Device Product Code and Panel Code: | Orthopedics/87/ LWJ, JDI, LZO, JDL, KWA |

#### DEVICE INFORMATION

#### A. INTENDED USE

The PROFEMUR® Tapered 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:

#### headquarters

| Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone | www.wmt.com |
|------------------------------------------------------------------------------------------|-------------|
| international subsidiaries | |

ariana 011.32.2.378.3905 Belgium 011-39-0250-678.227 Italy

905.826.1600 Canada 011.81.3.3536.0474 Japan 011.33.1.45.13.24.40 France 011.44.1463.721.404 UK

011.49.4161.745130 Germany

1

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- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, er
- revision procedures where other treatments or devices have failed 4.

## B. DEVICE DESCRIPTION

The design features of the PROFEMUR® Tapered Hip Stem are summarized below:

- Modular neck taper ●
- Tapered cylindrical distal stem .
- Plasma Sprayed proximal body .
- Grit blasted distal stem .
- Polished bullet tip ●
- . Spines

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and materials of the PROFEMUR® Tapered Hip Stem are identical to the PROFEMUR® Z Hip Stem. The design features of the PROFEMUR® Tapered Hip Stem are substantially equivalent to the PROFEMUR® Z Hip Stem, the PERFECTA® RS Hip Stem, and the PERFECTA® Plasma Sprayed Hip Stem. The safety and effectiveness of the PROFEMUR® Tapered Hip Stem 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 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Ms. Katie Logerot Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K04114

Trade/Device Name: PROFEMUR® Tapered Hip Stem Trace/Device Name: 1 ROPERTOS: 200, 21 CFR 888.3330, 21 CFR 888.3350, and 21CFR 888.3353

Regulation Names: Hip joint metal/metal semi-constrained, with a cemented acetabular Fift fount mount besis, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis and Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Regulatory Class: III Product Codes: JDL, KWA, JDI, LZO and LWJ Dated: April 26, 2004 Received: April 28, 2004

Dear Ms. Logerot:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answers wior 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 (sec above) into cither 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 he 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

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## Page 2 - Ms. Katie Logerot

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 (Scctions 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 yours,
Mark A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K041114

## Indications for Use

510(k) Number (if known):

Device Name: PROFEMUR® Tapered Hip Stem

Indications For Use:

The PROFEMUR® Tapered 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:

- 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

Prescription Use × (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)

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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number