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The OsteoCoil™ Nitinol Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of the small bones for wrist, hand, and foot.

This Traditional 510(k) is submitted to introduce the OsteoCoil™ Nitinol Compression System. The system consists of a 4.5mm, 6.5mm and 7.3mm screw available in 30mm in 5mm increment lengths and appropriate instrumentation to support implantation of the OsteoCol™ Nitinol Compression screws. The the OsteoCol™ Nitinol Compression System have the same technological characteristics as the predicate device, the Dynafuse Fixation System (K203595).

The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.

The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular support in the proximal ulna and olecranon.

The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.