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The FusionFrame Ring Lock System is indicated for: - · Stabilization of fractures and osteotomies; - · Bone deformity correction of lower extremities; - · Arthrodesis of the rear foot, mid foot and ankle joint; and - · Limb Lengthening in pediatric and adult patients.

This submission is a line extension to the FusionFrame™ Ring Lock System product line to include fixation pins, pin fixation bolts, pin fixation cubes, threaded sockets, conical washer couples, T-wrench and adapters, hinges, telescoping struts and 5/8 rings to improve the configuration options that the FusionFrame™ Ring Lock System can provide and to be competitively comparable to other circular external fixation predicate devices. The FusionFrame™ Ring Lock System is an updated version of previously existing circular fixators that is specifically designed for the treatment of pathologies including: - Stabilization of Fractures and Osteotomies. . - Bone deformity corrections of lower extremities. . - Arthrodesis of: . - 0 Rear Foot - 0 Mid Foot - 0 Ankle Joint - Adult and pediatric limb lengthening The Fusion Frame was developed to specifically address the extensive requirements of orthopedic surgeons and foot and ankle specialists. Its components have been designed to ensure overall construct stability, versatility, ease of application, functionality and time saving efficiency. Briefly described, the FusionFrame™ provides a weight bearing scaffold that in most cases allows patients to remain mobile throughout the course of treatment. The numerous variety of constructs afforded by the FusionFrame™ provides a systematic platform for ensuring stability, re-aligning bones, applying compressive forces or controlling the distraction of bone fragments over a period of time. The FusionFrame™ consists of externally mounted Rings and ancillary components that are interconnected with threaded rods and/or telescoping struts. The construct is attached to the bone with a combination of percutaneously applied tensioned Wires and/or Half-Pins. Telescoping struts with compression/distraction nuts may be attached to the frame to systematically control the gaps between bone fragments and distance between Rings to manage a variety of pathologies. Threaded rods or struts may be used to reduce and compress fracture zones, lengthen limbs and even correct deformities.