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The Zimmer Biomet™ Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet™ Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet™ Ceramic Heads. The heads are made from an alumina matrix composite. The Zimmer Biomet Ceramic Heads are supplied with a 12/14 bore or Type 1 bore and are offered in a variety of head diameters and neck configurations. They are intended for mating with a variety of Titanium Alloy and Cobalt-Chromium Alloy femoral stems equipped with tapered necks.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification for Zimmer Biomet Ceramic Heads, which details the device's classification, indications for use, and a summary of its technological characteristics and non-clinical and clinical tests. However, it does not specify acceptance criteria for performance or a study's results against those criteria.

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