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The Osteonics® Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6A14V alloy femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® 36mm Alumina C-Taper Head is intended for use with any appropriately selected Osteonics® Trident™ Polyethylene Inserts and associated Trident™ Acetabular Shell.

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous 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.

Osteonics® Alumina C-Taper Heads are alumina ceramic femoral bearings that have been designed for assembly, through a taper lock mechanism, to Ti6A14V alloy stems with the Osteonics® C-Taper trunnion design. This line extension to The Osteonics® Alumina C-Taper Heads adds the 36mm diameter size, with neck extensions of +0mm and +5mm. The subject heads are identical in material and design to the predicate heads.

Osteonics® Trident™ Polyethylene Inserts are manufactured from UHMWPE. They are compatible with Trident™ design Acetabular Shells. The subject inserts have an inner diameter of 36mm in order to mate with the subject 36mm alumina head.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for a medical device (Osteonics® Alumina C-Taper Heads and Osteonics® Trident™ Polyethylene Inserts) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information.

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