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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.

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.

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.

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