UNITRAX MODULAR UNIPOLAR SYSTEM

K014226 · Howmedica Osteonics Corp. · KWL · Jan 25, 2002 · Orthopedic

Device Facts

• Record ID: K014226
• Device Name: UNITRAX MODULAR UNIPOLAR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWL · Orthopedic
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Unitrax® Modular Unipolar System is intended to be used with a Howmedica Osteonics hip stem. When assembled to a hip stem, the resultant component functions as a hemi-hip endoprosthesis. The endoprosthesis is used as a hemi-arthroplasty for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.

Device Story

Unitrax® Modular Unipolar System is a hemi-hip endoprosthesis component; functions as a unipolar head. Device accepts neck adjustment adaptor/sleeve; assembles to Howmedica Osteonics femoral stem. Modifications include reduced wall thickness, removal of inner ribs, and manufacturing change for 45mm components from machined to cast. Used by orthopedic surgeons in clinical settings for hip reconstruction. Provides structural replacement for femoral head to restore joint function in patients with fractures or necrosis.

Clinical Evidence

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

Technological Characteristics

Modular unipolar hip head. Materials: Vitallium® (CoCr) alloy conforming to ASTM F75 (cast) and ASTM F1537 (wrought). Design features: reduced wall thickness, rib-less interior. Mechanical assembly to neck adjustment sleeve and femoral stem.

Indications for Use

Indicated for patients requiring hemi-hip arthroplasty due to femoral neck fractures, idiopathic avascular necrosis, or non-unions.

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.

Predicate Devices

• Unitrax® Modular Unipolar System (K902365)

Submission Summary (Full Text)

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014226

JAN 2 5 2002

## Special 510(k) Summary - Device Modifications for the UNITRAX® MODULAR UNIPOLAR SYSTEM

| Proprietary Name: | Unitrax® Modular Unipolar System |
|------------------------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Unipolar Head |
| Classification Name and Reference: | 888.3360<br>Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis. |
| Proposed Regulatory Class: | II |
| Device Product Code: | KWL |
| For Information Contact: | Jennifer A. Daudelin, Regulatory Affairs |
| | Howmedica Osteonics Corp. |
| | 59 Route 17 |
| | Allendale, NJ 07401-1677 |
| | [phone] |
| | Fax: [phone] |

This Special 510(k) submission is intended to address design, manufacturing process, and material modifications to the Unitrax® Modular Unipolar System. The Unitrax® component is a unipolar head that accepts a neck adjustment adaptor or sleeve. The neck adjustment sleeve is then assembled to the trunnion of the desired Howmedica Osteonics femoral stem. The design modification to the unipolar head involves a reduction in the wall thickness and removal of the inner "ribs". The manufacturing process modification involves changing the size 45mm components from machined to cast parts which results in a material change from ASTM F1537 to ASTM F75. The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365. The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) and F1537 (wrought). The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics, Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K014226

Trade/Device Name: Unitrax® Modular Unipolar System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWL Dated: December 21, 2001 Received: December 26, 2001

Dear Ms. Daudelin:

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 - Ms Jennifer Daudelin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

L. Mark N. Milburn

Celia M. 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

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510(k) Number (if known):

K014226

Unitrax® Modular Unipolar System Device Name:

Indications for Use:

The Unitrax® Modular Unipolar System is intended to be used with a Howmedica The Onlines hip stem. When assembled to a hip stem, the resultant component functions in Ostcomes imp stem. "When assemmooprosthesis. The endoprosthesis is used as a hemia shillial for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over The-Counter Use
(Per 21 CFR 801.109)

Mark N Millken (Optional Format 1-2-96)

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

510(k) Number K014226