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The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

Indications for Use as a Bipolar

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

Indications for Use as a Total Hip:

• 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,
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

The Howmedica Osteonics Biolox delta ceramic femoral heads will now be available in a universal taper with available metal sleeves which accommodate C-taper® and V40® taper femoral stems. The modified ceramic femoral heads will be available in diameters from 28mm to 44mm. The metal sleeves will be available in a variety of offsets.

The subject devices are sterile, single use devices. The Universal Taper Biolox delta femoral heads and metal adaptor sleeves can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or Cobalt Chrome alloys. The stainless steel metal adaptors are can be used with all Howmedica Osteonics stainless steel stems. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.

The provided documentation for K070885, the Universal Taper Delta Femoral Head, does not contain information regarding objective performance criteria (e.g., sensitivity, specificity, accuracy, or a specific mechanical strength threshold) or the results of a study designed to demonstrate that the device meets such criteria.

The 510(k) submission for this device is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data against predefined acceptance criteria. This type of submission (510(k)) typically relies on comparisons to existing devices for safety and effectiveness rather than extensive de novo clinical trials or setting new performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes the device, its intended use, indications for use, and confirms its clearance by the FDA through the 510(k) process based on substantial equivalence.

Without this information in the provided text, the table and other requested details cannot be generated.

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