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The DARCO Force Titanium Compression Screw is to be used on indications that are common for currently marketed compression screws. The primary indication for use is the fixation and stabilization of the fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsal, carpals and metacarpals, bunionectomies and osteotomies, arthrodesis of small joints (e.g. phalanges).

The DARCO Force Compression Screw is a self drilling, self tapping and self counter sinking 3.2mm hex drive cannulated screw with a reverse cutting nib designed into the thread pattern. The cannulated feature allows for the use of a drill guide for precise placement while the smooth shank between the threaded portions of the screw allows the bone surfaces to be compressed to facilitate healing. The screws are made of Ti 6-Al 4-V biocompatible titanium alloy and coated with an anodized finish.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the DARCO Force Compression Screw, indicating that no clinical tests were used in the claim of substantial equivalence (page 0). This means that the device's equivalence to a predicate device was established through technological characteristics rather than performance data from a specific study.

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