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The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:

• Manufactured from Cobalt Chrome Alloy
• 12 Sizes in 2mm increments
• Plasma Spray undersurface

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it describes a substantial equivalence determination for a medical device.

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Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The all-metal cobalt chrome TARA Resurfacing device is a single unit component and is porous coated on the inner cylindrical wall and ceiling only. The cobalt chrome porous coating is a -45 +60 Mesh x .030" thick surface coating. The all-metal TARA is only avaiable in the short stem version, again with nine head sizes from 38mm to 55mm in 2 mm increments. The all-metal TARA is fixed to the bone with cement.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary and an FDA clearance letter for the BIOPRO TARA Femoral Resurfacing Component. These documents outline the device's substantial equivalence to predicate devices, its intended use, and its classification. They do not detail specific performance acceptance criteria or report on studies designed to demonstrate the device meets such criteria. Typically, performance data and acceptance criteria are found in a separate section of the 510(k) submission, not summarized in these publicly available portions.

Therefore, I cannot provide the requested information based on the given text.

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