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The use of the Implex Hip System is indicated for: a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis, b) Secondary revision of a previously unsuccessful femoral component or total hip replacement, c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results, d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved, e) Non-union or femoral neck or head fractures, f) Salvage of a failed primary or secondary total or hemi hip.

The Trabecular Metal Monoblock Acetabular Cup is manufactured from Trabecular Metal (Hedrocel Porous Tantalum), titanium alloy (Ti-6Al-4V), and direct compression molded ultra-high molecular weight polyethylene (UHMWPE). It is available with an ID of 28 mm, an OD range of 48 - 70 mm in 2 mm increments, and possesses a hybrid 0 - 10-degree face angle. The device utilizes the same instrumentation and surgical protocol as the Hedrocel and Trabecular Metal Monoblock Cups (K964509 and K003181). These acetabular devices are intended for use with Zimmer and Implex Components as described in K003181.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a medical device (The Trabecular Metal Monoblock Acetabular Cup), which details its description, indications for use, and a letter from the FDA determining substantial equivalence to predicate devices. It does not contain any performance data, clinical study results, or acceptance criteria.

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