ATH FEMORAL STEM

K034028 · Wrightmedicaltechnologyinc · JDI · Mar 11, 2004 · Orthopedic

Device Facts

• Record ID: K034028
• Device Name: ATH FEMORAL STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JDI · Orthopedic
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATH Femoral 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; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques.

Device Story

ATH Femoral Stem is a hip prosthesis component used in total hip arthroplasty. Device features include sizes 4mm-13mm, standard 12/14 SLT taper, and grit blast surface finish. Design incorporates a proximal body with double-wedge shape and rounded-off rectangular cross-section, a tapered distal stem with rounded-off rectangular cross-section, and a lateral shoulder dimple. Used by orthopedic surgeons in clinical settings to replace diseased or damaged hip joints, aiming to reduce pain and restore function.

Clinical Evidence

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

Technological Characteristics

Hip prosthesis; metal/polymer construction. Features 12/14 SLT taper, grit blast surface finish, double-wedge proximal body, and tapered distal stem with rounded-off rectangular cross-section. Sizes range from 4mm to 13mm.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory/inflammatory degenerative joint disease (e.g., osteoarthritis, rheumatoid arthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), functional deformity correction, revision procedures, or fracture treatment.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a document with the text "510(K) SUMMARY OF SAFETY AND EFFECTIVENESS" and the Wright Medical logo. The document also has the date "MAR 11 2004" and the handwritten text "K034028 page 1 of 2". The document appears to be a summary of safety and effectiveness for a medical device.

In accordance with the Food and Drug Administration Rule to implement provin Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information scrves as a Summary of Safety and Effectiveness for the ATH Femoral Stem.

510(K) SUMMARY

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------------|
| Date: | December 19, 2003 |
| Contact Person: | Jeanine H. Redden<br>Regulatory Affairs Associate |
| Proprietary Name: | ATH Femoral Stem |
| Common Name: | HIP PROSTHESIS |
| Classification Name and Reference: | 21 CFR 888.3358 Prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented- Class II |
| | 21 CFR 888.3350 Prosthesis, hip, semi-constrained,<br>metal/polymer, cemented- Class II |
| Device Product Code and Panel Code: | Orthopedics/87/LPH/JDI |

### DEVICE INFORMATION

### A. INTENDED USE

The ATH Femoral 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 discase such as 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.

## B. DEVICE DESCRIPTION

The design features for Wright Medical Technology's ATH Femoral Stem are as follows:

- Sizes range from 4mm to 13mm .
- Wright Medical Technology's standard 12/14 SLT taper .
- . Grit blast surface finish

#### headquarters

5677 Airline Boad Arlington, IN 38002 Wright Medical Technology, Inc.

901.867.9971 phone

www.wmt.com

international subsidianes 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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K034028
page 2 of 2

And Children Children Children

- Proximal body with double wedge shape .
- Proximal body has rounded off rectangular cross-section .
- Tapered distal stem with rounded off rectangular cross-section .
- Dimple on lateral shoulder .

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

Wright Medical Technology's ATH Femoral Stem is substantially cquivalent to the wing.it insured "Founded" "The safety and effectiveness of the ATH predicate actives provised by the substantial equivalent information, matcrials data, and testing results provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wings, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAR 1 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K034028

Trade/Device Name: ATH Femoral Stem Implant Regulation Numbers: 21 CFR 888.3350 and 21 CFR 888.3358 Regulation Names: Spinal interlaminal fixation orthosis, Hip joint metal/polymer/metal semi-constrained pouous-coated uncemented prosthesis Regulatory Class: II Product Codes: JDI and LPH Dated: February 20, 2004 Received: February 23, 2004

Dear Ms. Redden:

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. Jeanine H. Redden

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 McMillan

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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# Indications for Use

510(k) Number: K034028

ATH Femoral Stem Device Name:

Indications For Use:

The ATH Femoral 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;
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of fractures that are unmanageable using other techniques.

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)

Mark N Milliman

1. Restorative and Neurological Devices

Page 1 of 1

**510(k) Number** K034028