The Osteonics® Omnifit®-C Cemented Hip Stems are intended for single-use in patients requiring hemi-hip replacement, bi-polar hip replacement, or total hip replacement. The Osteonics® Omnifit®-C Cemented Hip Stems are intended for cemented applications.

For use as a bipolar or hemi-hip replacement:

Femoral head/neck fractures or non-unions. .
Aseptic necrosis of the femoral head. .
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other considerations

Pathological conditions or age considerations that indicate a more conservative . acetabular procedure and an avoidance of use of bone cement in the acetabulum.
Salvage of a failed total hip arthroplasty. .

For use as a total hip replacement:

Painful, disabling joint disease of the hip 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.

Device Description

The modified Osteonics® Omnifit®-C Cemented Hip Stems have the same design as the predicate Osteonics® Omnifit®-C Cemented Hip Stems, except that the modified components feature a 5mm longer neck.

AI/ML Overview

This K97246J 510(k) submission for the Osteonics® Omnifit®-C Cemented Hip Stems does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document describes a line extension for existing hip stems, where the primary change is a 5mm longer neck. The manufacturer argues that this modification is "non-significant" because the increased neck length is compensated by contraindicating the modified stem for use with +10mm heads.

Specifically, the "Performance Data" section states: "No mechanical testing is required to demonstrate the substantial equivalence of the subject device to its predicate version." This indicates that the manufacturer did not perform new tests with acceptance criteria for this specific 510(k) submission.

Therefore, I cannot provide the requested information.

Summary

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K97246J

510(k) Summary

510(k) Summary Osteonics® Omnifit®-C Cemented Hip Stems

Submission Information

Name and Address of the Sponsor:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Contact Person:	Terry SheridanRegulatory Affairs Specialist
Date of Summary Preparation:	June 30, 1997
Device Identification
Proprietary Name:	Osteonics® Omnifit®-C Cemented HipStems (Line Extension)
Common Name:	Artificial hip joint component, femoralstem
Classification Name and Reference:	Hip Joint Metal/PolymerSemi-constrained Cemented Prosthesis§888.3350

Predicate Device Identification

The subject Osteonics® Omnifit®-C Cemented Hip Stems are substantially equivalent to the predicate Osteonics® Omnifit®-C Cemented Hip Stems.

Device Description

Intended Use:

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1000 12000

Indications

For use as a bipolar or hemi-hip replacement:

Femoral head/neck fractures or non-unions. .
Aseptic necrosis of the femoral head. .
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other considerations

Pathological conditions or age considerations that indicate a more conservative . acetabular procedure and an avoidance of use of bone cement in the acetabulum.
Salvage of a failed total hip arthroplasty. .

For use as a total hip replacement:

Painful, disabling joint disease of the hip 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.

Statement of Technological Comparison:

The subject Osteonics® Omnifit®-C Cemented Hip Stems are identical to the predicate Osteonics® Omnifit®-C Cemented Hip Stems except that the subject devices feature a neck length that is 5mm greater. This modification is non-significant, however, because the 5mm gained on the stem side have been compensated for by subtracting 5mm on the femoral head side (i.e., by contraindicating the modified stem for use with +10mm heads).

Performance Data:

No mechanical testing is required to demonstrate the substantial equivalence of the subject device to its predicate version. In effect, 5mm of offset have been shifted from the head side (in the case of the predicate device) to the stem side (in the case of the subject device). Therefore, the most severe predicate device combination remains equivalent to the most severe subject device combination.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry Sheridan Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

SEP 2 5 397

K972460 Re: Osteonics® OmniFit®-C Cemented Hip Stems Trade Name: Regulatory Class: II Product Code: JDI Dated: June 30, 1997 Received: July 1, 1997

Dear Ms. Sheridan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Paqe 2 - Ms. Terry Sheridan

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972460

Device Name: Osteonics® Omnifit®-C Cemented Hip Stems

Indications For Use:

Indications

For use as a bipolar or hemi-hip replacement:

Femoral head/neck fractures or non-unions. .
Aseptic necrosis of the femoral head. .
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other considerations

Pathological conditions or age considerations that indicate a more conservative acetabular . procedure and an avoidance of use of bone cement in the acetabulum.
Salvage of a failed total hip arthroplasty. .

For use as a total hip replacement:

Painful, disabling joint disease of the hip 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) Division of Ceneral Restorative Devices 510(k) Number 19976460

Regulation Number and Section

N/A