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The BTI™ brand Large (7.0 mm) Cannulated Transfixing Screw is indicated for single use with the BTI brand Proximal Humeral Intramedullary Rod, the BTI brand Mid-Shaft Humeral Intramedullary Rod and the BTI brand Tod, the Britishedullary Rod Systems to stablifize fractures.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "BTI Large (7.0 mm) Transfixing Screw." It does not describe the acceptance criteria or a study that proves the device meets those criteria. Instead, it indicates that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance and provides instructions on labeling and permissible uses of the device, particularly regarding its non-use for pedicular screw fixation.

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