OMNIFIT HFX HIP STEM SERIES

K031744 · Howmedica Osteonics Corp. · JDI · Aug 8, 2003 · Orthopedic

Device Facts

• Record ID: K031744
• Device Name: OMNIFIT HFX HIP STEM SERIES
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.

Device Story

Omnifit® HFx Hip Stem Series are femoral hip stems for total or bipolar hip arthroplasty. Devices are forged from cobalt chromium alloy; intended for single use; compatible with bone cement or cementless fixation. Used in conjunction with modular components including Endo Head and Neck Extensions, UHR® Universal Heads, or C-Taper heads and acetabular components. Operated by orthopedic surgeons in clinical/hospital settings. Device provides structural replacement for diseased or fractured femoral head/neck; restores joint function; alleviates pain. Strength of neck and body regions validated via Finite Element Analysis.

Clinical Evidence

Bench testing only. Finite Element Analysis was performed to evaluate the strength of the neck and body regions of the hip stems.

Technological Characteristics

Materials: ASTM F-799 cobalt chromium alloy. Design: Femoral hip stem for cemented or uncemented use. Connectivity: None (mechanical implant). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for bipolar hip replacement in patients with femoral head/neck fractures or non-union, aseptic necrosis, or arthritis (osteo-, rheumatoid, post-traumatic) with minimal acetabular involvement; also for patients requiring conservative acetabular procedures or salvage of failed total hip arthroplasty. Indicated for total hip replacement in patients with painful, disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis, or late-stage avascular necrosis), revision of failed previous procedures, clinical management problems where arthrodesis is less satisfactory, or clinical circumstances requiring altered femoral resection due to proximal fracture, bone loss, or calcar lysis.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Osteonics ODC/ODC Plus Hip Stems
• Omnifit X (Eon) Hip Stems

Reference Devices

• 6076 series hip stems (K954598)

Submission Summary (Full Text)

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AUG - 8 2003

Omnifit® HFx Hip Stcms

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# 510(k) Summary: Omnifit® HFx Hip Stem Series

| Proprietary Name: | Omnifit® HFx Hip Stem Series |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Femoral Hip Stems |
| Classification Name and Reference: | Hip joint, metal/polymer semi-constrained,<br>cemented prosthesis<br>21 CFR §888.3350<br>Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis<br>21 CFR §888.3360 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 – JDI: Prosthesis, hip, semi-constrained,<br>cemented<br>87 – LWJ: Prosthesis, hip, semi-constrained,<br>metal/polymer, uncemented |
| Predicate Proprietary Name(s): | Osteonics ODC/ODC Plus Hip Stems, Omnifit X<br>(Eon) Hip Stems |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | 87 JDI, KWL |
| Submitted By: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, New Jersey 07401-1677<br>[phone] |
| Contact Information: | Debra Bing<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | July 23, 2003 |

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#### Omnifit® HFx Hip Stems

## Description/Technological Comparison

031744

The subject and predicate hip stems are both hip fracture stems intended for cemented use. The subject devices and the predicate 6076 series hip stems (K954598) are forged from ASTM F-799 cobalt chromium alloy.

## Intended Use

The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.

## Indications:

For use as a bipolar hip replacement

- Femoral head/neck fractures or non-union, .
- Asentic necrosis of the femoral head, ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acctabular . involvement or distortion,
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
- Salvage of failed total hip arthroplasty .
- Femoral Neck Fractures .

### For use as a total hip replacement

- Painful, disabling joint disease resulting from: degenerative arthritis, rheumatoid arthritis, ● post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other . procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results,
- Clinical circumstances that require an altered femoral resection level due to proximal ● fracture, bone loss, or calcar lysis.

## Testing Summary

Finite Element Analysis was used to evaluate the strength of the neck and body regions of the hip stems.

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Public Health Service

AUG - 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Bing Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401

Re: K031744 Trade/Device Name: Omnifit® HFx Hip Stem Series Regulation Number: 21 CFR 888.3350 and 21 CFR 888.3360 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis and Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, and KWL Dated: June 4, 2003 Received: June 5, 2003

Dear Ms. Bing:

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. Debra Bing

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 [phone]. 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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510(k) Number (if known):

Device Name: Omnifit® HFx Hip Stem Series

The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.

### Indications:

### For use as a bipolar hip replacement

- Femoral head/neck fractures or non-union, .
- Aseptic necrosis of the femoral head, ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular ● involvement or distortion,
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
- . Salvage of failed total hip arthroplasty
- Femoral Neck Fractures .

### For use as a total hip replacement

- Painful, disabling joint disease resulting from: degenerative arthritis, theumatoid arthritis, . post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other . procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
- Clinical circumstances that require an altered femoral resection level due to proximal fracture, . bone loss, or calcar lysis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|------------------|--|
|------------------|--|

OR

| Over-The-Counter Use | | (Per 21 CFR 801.109) |
|----------------------|--|----------------------|
|----------------------|--|----------------------|

(Optional Format 1-2-96)

*Miriam C. Provost*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

| 510(k) Number | K031744 |
|---------------|---------|
|---------------|---------|

TOTAL P.21