SOLITUDE UNIPOLAR HEAD

K042973 · Ortho Development Corp. · KWL · Jan 27, 2005 · Orthopedic

Device Facts

• Record ID: K042973
• Device Name: SOLITUDE UNIPOLAR HEAD
• Applicant: Ortho Development Corp.
• Product Code: KWL · Orthopedic
• Decision Date: Jan 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solitude™ Unipolar femoral head is intended for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis. 2. Proximal femoral neck fractures or dislocation. 3. Idiopathic avascular necrosis of the femoral head. 4. Non-union of proximal femoral neck fractures. 5. Treatment of fractures that are unmanageable using other forms of therapy.

Device Story

Solitude™ Unipolar Head is a metallic femoral prosthesis component for hip hemi-arthroplasty. Device replaces femoral head in primary or revision procedures; used with cemented or uncemented femoral stems. Implanted by orthopedic surgeons in clinical/OR settings. Provides structural replacement for damaged femoral head; restores hip joint function; alleviates pain associated with arthritis, necrosis, or fractures. Device serves as mechanical interface between acetabulum and femoral stem.

Clinical Evidence

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

Technological Characteristics

Metallic femoral head prosthesis for hip hemi-arthroplasty. Designed for use with cemented or uncemented femoral stems. Class II device (21 CFR 888.3360).

Indications for Use

Indicated for patients requiring hemi-arthroplasty due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, proximal femoral neck fractures/dislocation, idiopathic avascular necrosis of the femoral head, or non-union of proximal femoral neck fractures.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's symbol, which consists of a stylized caduceus with three strands intertwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2005

Mr. William J. Griffin Regulatory and Clinical Affairs Manager Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

Re: K042973

Trade/Device Name: Solitude™ Unipolar Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: KWL Dated: January 6, 2005 Received: January 7, 2005

Dear Mr. Griffin:

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. William Griffin

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 240-276-0120. 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 vours.

Mark A. Millerson

Celia 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 of Device Form

510(k) Number (if known): ___ K042973

Device Name: Solitude™ Unipolar Head

Indications for Use

The Solitude™ Unipolar femoral head is intended for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include:

- 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
- Proximal femoral neck fractures or dislocation. 2.
- 3. Idiopathic avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures. ধ
- 5. Treatment of fractures that are unmanageable using other forms of therapy.

| Prescription Use | |
|-----------------------------|--|
| Use | |
| (Part 21 CFR 801 Subpart D) | |

Over-The-Counter

(Part 21 CFR 801 Subpart C)

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AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

fo

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number K042973