PROFEMUR LX HIP STEM

K053588 · Wrightmedicaltechnologyinc · KWA · Jan 13, 2006 · Orthopedic

Device Facts

• Record ID: K053588
• Device Name: PROFEMUR LX HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROFEMUR® LX 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.

Device Story

PROFEMUR® LX Hip Stem is a prosthetic hip implant used in total hip arthroplasty. Device features titanium alloy (Ti6Al4V) construction; tri-planar proximal geometry with plasma-sprayed surface; cylindrical, splined, and slotted distal stem with glassbead surface; threaded hole with slot impaction mechanism; polished distal tip and collar. Implanted by orthopedic surgeons in clinical/OR settings to replace diseased hip joints. Provides structural support and joint articulation to reduce pain and restore function in patients with degenerative or inflammatory joint disease. Benefits include improved mobility and relief from joint pain.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design analysis and materials information.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V). Design: Tri-planar proximal geometry with plasma-sprayed surface; cylindrical, splined, and slotted distal stem with glassbead surface; polished distal tip and collar. Features threaded hole with slot impaction mechanism. Non-active, mechanical orthopedic implant.

Indications for Use

Indicated for skeletally mature patients requiring total hip arthroplasty 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)

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### JAN 1 3 2006 1 of 2 Ko53588 ( Ca

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe m accordance with the 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® LX Hip Stem.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | January 11, 2006 |
| Contact Person: | Theresa Leister |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | PROFEMUR® LX Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 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 888.3353 Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented- Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ LZO, JDL, KWA |

#### DEVICE INFORMATION

#### A. INTENDED USE

The PROFEMUR® LX 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.

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K053588 (pg 2 of 2)

#### B. DEVICE DESCRIPTION

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

- Manufactured from titanium alloy (Ti6A14V) .
- Offered in one medial flare option .
- Tri-planar proximal geometry with plasma sprayed surface .
- Cylindrical, splined, and slotted distal stem with glassbead surface .
- Threaded hole with slot impaction mechanism .
- Polished distal tip and collar .

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Theresa Leister Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K053588 Trade/Device Name: PROFEMUR® LX Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Regulatory Class: III Product Code: KWA, LZO, JDL Dated: December 22, 2005 Received: December 23, 2005

Dear Ms. Leister:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 cither class II (Special Controls) or class III (PMA), they 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 devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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#### Page 2 - Ms. Leister

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply will an the Not 800 (2008) Part 801); good manufacturing practice requirements as set CFR Part 807); mooning (Dr CFR Part 820); and if applicable, the electronic forth in the quality byotens (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) This letter will anow you're ough finding of substantial equivalence of your device to a legally premits to the are 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 If you desire specific ac arroliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

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Sincerely yours,

2

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

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:ELF:rrr: 1/12/06

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# KOS3588

# Indications for Use

510(k) Number (if known):

Device Name: PROFEMUR® LX Hip Stem

Indications For Use:

indications For Ose.
The PROFEMUR® LX Hip Stem is indicated for use in total hip arthroplasty for THE TROFEMOR® DA REP START Proved hip function in skeletally mature patients with the following conditions:

- I 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.
- correction of functional deformity; and, 3.
- 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 ( )

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of General. Restorative, and Neurological Devices

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**510(k) Number** K053588

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