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The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The Pin Screws have a tapered thread diameter and are available in a variety of diameter and lengths in both cortical and cancellous thread patterns. The Pin Screws will be available with and without the additional proprietary self-drilling on the threads. The Pin Screws are manufactured from surgical grade stainless steel, 316L per BK MEDITECH CO.,LTD. ASTM F138. The Pin Screws are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures. The Pin Screws are provided non-sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document.

This document is a 510(k) summary for the "Pin Screw" device, seeking regulatory clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot extract the requested information from the provided text as the document focuses on regulatory submission and equivalence, not a performance study.

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