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The Osteonics® Extended Femoral Bearing Heads are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® Extended Femoral Bearing Heads are designed to accommodate a patient population requiring extended offset provided by a plus 12.5mm or a plus 15mm femoral head option when used in conjunction with the Osteonics® Femoral Stems specified in this submission.

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 for use as a Bipolar or Hemi-Hip Replacement:

• 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.

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 Osteonics® Extended Femoral Bearing Heads are ASTM F-799 Cobalt chromium alloy devices available in two female taper configurations, a Morse Taper and a European Taper (Osteonics` trade name "C-Taper"). The devices are spherical in design and are available in 22, 26, 28, and 32mm diameters with +12.5mm and +15mm neck extensions. The outer surface of the Osteonics® Extended Femoral Bearing Heads are highly polished and are available both with and without nitrogen ion surface treatment.

The provided document is a 510(k) Premarket Notification Summary for the Osteonics® Extended Femoral Bearing Head. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance data from a new study designed to meet specific acceptance criteria of the device itself.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's a breakdown of why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Study: The document explicitly states under "Performance Data": "The comparison of the Osteonics® Extended Femoral Bearing Head to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary." This indicates that no new performance tests or studies were conducted for this submission with specific acceptance criteria that the device was tested against.
• Substantial Equivalence, Not De Novo Performance: The entire submission relies on establishing "substantial equivalence" to already legally marketed predicate devices (Osteonics® Morse Taper Heads, Osteonics® C-Taper Heads, and DePuy Articule-Eze® Total Hip Balls). This means the device is considered safe and effective because its design, materials, and intended use are similar to products already on the market, not because it met new, independently defined performance metrics through a dedicated study.

In summary, the document does not contain the information needed to fill out the requested table or answer the specific questions about a performance study, acceptance criteria, sample sizes, or ground truth establishment.

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