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The Indications for Use of the Trabecular Metal Acetabular Revision Shells are:

• For cemented or cementless use. .
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problem where arthrodesis or . alternative reconstruction techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for 1 reconstructive techniques as indicated by other deficiencies of the acetabulum.

The Trabecular Metal Acetabular Revision Shell is a modular acetabular reconstructive device (polyethylene liner is cemented to shell) intended for use in primary or revision reconstructive procedures of the acetabulum. The subject Trabecular Metal Acetabular Revision Shell is manufactured from Trabecular Metal porous tantalum. The TM Revision Shell has a Ti-6A1-4V instrument interface ring (ASTM F-136) along its outer perimeter that provides a rigid contact area for the impaction instrument used to implant the device. The Revision Shells are intended for either cementless or cemented fixation to the acetabulum with that allow for optional ancillary fixation to the acetebulum. The screwholes mate with commercially available Zimmer 6.5mm titanium allov bone screws.

The Trabecular Metal Acetabular Revision Shell is a medical device. The provided text is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not include information on acceptance criteria and a study proving device performance as would be found in a clinical trial or performance study report. Instead, substantial equivalence is established through comparisons to predicate devices.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary. The document focuses on device description, indications for use, and a declaration of substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

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