PROFEMUR LX REVISION 5/8 COATED HIP STEM

K080663 · Wrightmedicaltechnologyinc · KWA · Apr 8, 2008 · Orthopedic

Device Facts

• Record ID: K080663
• Device Name: PROFEMUR LX REVISION 5/8 COATED HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Apr 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROFEMUR® LX Revision 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 ioint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed The PROFEMUR® L.X Revision 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

Device Story

PROFEMUR® LX Revision 5/8 Coated Hip Stem; titanium alloy (Ti6Al4V) femoral component for cementless total hip arthroplasty. Features plasma-sprayed proximal 5/8 section; polished distal tip and collar; threaded hole with slot impaction mechanism. Sizes 13-21. Used by orthopedic surgeons in clinical/OR settings to replace diseased or failed hip joints. Provides structural support for hip joint; restores function; reduces pain. Implanted via surgical procedure.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy (Ti6Al4V) construction; plasma-sprayed proximal 5/8 surface; polished distal tip and collar; threaded hole with slot impaction mechanism; sizes 13-21; cementless fixation.

Indications for Use

Indicated for skeletally mature patients requiring total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, or revision of failed prior treatments.

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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# APR - 8 2008

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

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

January 24, 2008

Ryan Ross

Regulatory Affairs Specialist

PROFEMUR® LX Revision 5/8 Coated Hip Stem

Hip Stem

21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III

Device Product Code and Panel Code:

Orthopedics/87/ KWA, LZO. MBL

#### DEVICE INFORMATION

#### A. Intended Use

The PROFEMUR® LX Revision 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 ioint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed

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

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#### B. Device Description

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

- Manufactured from titanium alloy (Ti6Al4V) .
- Proximal 5/8 of stem plasma sprayed .
- Offered in Sizes 13-21
- Polished distal tip and collar
- Threaded hole with slot impaction mechanism

### C. Substantial Equivalence Information

The indications for use of the PROFEMUR® LX Revision 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 Revision 5/8 Coated Hip Stem is 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

# APR - 8 2008

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

K080663 Re: Trade/Device Name: Profemur LX Revision % 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: January 24, 2008 Received: March 10, 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.

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#### 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 the reporting 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 M. Millican

Mark N. Melkerson 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 (if known):

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

Indications For Use:

The PROFEMUR® LX Revision 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;
- 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 Revision 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)

Nula P. Ogden for nkm

Division of General. Restorative and Neurological Devices

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510(k) Number K080663