PROFEMUR LX 5/8 COATED HIP STEM

K081090 · Wrightmedicaltechnologyinc · KWA · May 15, 2008 · Orthopedic

Device Facts

• Record ID: K081090
• Device Name: PROFEMUR LX 5/8 COATED HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROFEMUR® LX 5/8 Coated 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. The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

Device Story

PROFEMUR® LX 5/8 Coated Hip Stem is a femoral component for cementless total hip arthroplasty. Device is implanted by orthopedic surgeons in a clinical/OR setting to replace the femoral head/neck in patients with degenerative joint disease or functional deformity. Features titanium alloy (Ti6Al4V) construction with plasma-sprayed proximal 5/8 coating for osseointegration and a polished distal tip/collar. Includes a threaded hole with a slot impaction mechanism for surgical insertion. Provides structural support for hip joint reconstruction, aiming to reduce pain and restore function. No electronic or software components.

Clinical Evidence

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

Technological Characteristics

Titanium alloy (Ti6Al4V) hip stem; proximal 5/8 plasma-sprayed coating; polished distal tip and collar; sizes 10-18; threaded hole with slot impaction mechanism; cementless fixation.

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. Intended for cementless use.

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}------------------------------------------------

K081090 (pg 1/2)

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 15 2008

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 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® LX 5/8 Coated Hip Stem.

| Submitted By: | Wright Medical Technology, Inc. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 28, 2008 |
| Contact Person: | Ryan Ross<br>Regulatory Affairs Specialist |
| Proprietary Name: | PROFEMUR® LX 5/8 Coated Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/ metal semi-<br>constrained, with an uncemented acetabular<br>component prosthesis - Class III |

Device Product Code and Panel Code:

Orthopedics/87/ KWA. LZO. MBL

### DEVICE INFORMATION

#### A. Intended Use

The PROFEMUR® LX 5/8 Coated 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

The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

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

# KOBIO90 (pg 212)

#### B. Device Description

The design features of the PROFEMUR® LX 5/8 Coated Hip Stem are summarized below:

- Manufactured from titanium alloy (Ti6A14V) ●
- Proximal 5/8 of stem plasma sprayed .
- . Offered in Sizes 10-18
- Polished distal tip and collar .
- Threaded hole with slot impaction mechanism .

### C. Substantial Equivalence Information

The indications for use of the PROFEMUR® LX 5/8 Coated Hip Stem are identical to the previously cleared predicate devices. The design features and materials of the subject devices 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® LX 5/8 Coated Hip Stem is 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 seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, which is a staff entwined with snakes, representing medicine and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Ryan Ross Regulatory Affairs Specialist 5677 Airline Road Arlington, TN 38002

MAY 15 2008

K081090 Re: Trade/Device Name: PROFEMUR® LX 5/8 Coated 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, LZO, MBL Dated: April 14, 2008 Received: April 18, 2008

Dear Mr. Ross:

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.

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

Page 2 - Mr. Ryan Ross

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K081090 (pcs) / 1 )

Device Name: PROFEMUR® LX 5/8 Coated Hip Stem

Indications For Use:

The PROFEMUR® LX 5/8 Coated 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.

The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

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)

Milke Oil for men

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K081090

1