PROFEMUR TL HIP STEM

K060358 · Wrightmedicaltechnologyinc · KWA · May 10, 2006 · Orthopedic

Device Facts

• Record ID: K060358
• Device Name: PROFEMUR TL HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROFEMUR® TL 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, 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

PROFEMUR® TL Hip Stem is a femoral component for total hip arthroplasty; used by orthopedic surgeons in clinical settings. Device features flat tapered wedge body; rectangular cross-section with radiussed sides; titanium alloy construction; glass bead surface finish with proximal plasma spray coating. Includes modular neck taper; dimple and cross slot impaction mechanism for surgical insertion. Implanted to replace diseased femoral head/neck; restores joint function; reduces pain. No software or electronic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological characteristics.

Technological Characteristics

Wrought or forged titanium alloy (ASTM F136 or F620). Flat tapered wedge body; rectangular cross-section with radiussed medial/lateral sides. Sizes 1-12. Glass bead surface finish with proximal plasma spray coating. Modular neck taper. Dimple and cross slot impaction mechanism.

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)

{0}------------------------------------------------

K060358 (pg 1 of 2)

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

l

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® TL Hip Stem.

| Submitted By: | Wright Medical Technology, Inc. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | February 10, 2006 |
| Contact Person: | Matt Paul |
| | Regulatory Affairs Specialist |
| Proprietary Name: | PROFEMUR® TL Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21CFR 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 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented - Class II |
| | 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/ LWJ, JDI, LZO, JDL, KWA

{1}------------------------------------------------

K060358 (pg 2 of 2)

#### DEVICE INFORMATION

#### A. INTENDED USE

The PROFEMUR® TL 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, 3.
- revision procedures where other treatments or devices have failed 4.

#### B. DEVICE DESCRIPTION

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

- Wrought or forged titanium alloy (ASTM F136 or F620) .
- Body shape is a flat tapered wedge .
- Cross-section is rectangular with radiussed medial and lateral sides .
- Size range 1-12 .
- Glass bead surface finish, with proximal plasma spray coating .
- Neck taper for use with modular necks .
- Dimple and cross slot impaction mechanism .

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and materials of the PROFEMUR® TL Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® TL Hip Stem 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 PROFEMUR® TL Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

Mr. Matt Paul Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K060358

Trade/Device Name: PROFEMUR® TL Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LWJ, JDI, LZO Dated: April 10, 2006 Received: April 12, 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 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

{3}------------------------------------------------

#### 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/industry/support/index.html.

Sincerely yours,

Helene Lemer MD

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

Enclosure

{4}------------------------------------------------

# K060358

## Indications for Use

510(k) Number (if known):

Device Name:_PROFEMUR® TL_Hip Stem

Indications For Use:

The PROFEMUR® TL 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;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- 3. correction of functional deformity; and.
- 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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulst

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K060358