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The Impact Medical, LLC screws, plates, and K-Wires are single use, non-sterile and are indicated for use in: - . Fixation and stabilization of fractures in small and long bones; including at a minimum: the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle foot bones, calcaneus and for fixation of fractures in the proximal femur and trochanteric, intertrochanteric, and basilar neck fractures. - . Kirschner (K) wires are used in support of fracture fixation, for ostedtomies in the presence of adequate immobilization and implant guide wires.

The Impact Medical, LLC Orthopedic Fixation Systems (OFS) consists of various plates, screws and K-Wires that can be provided in sets or individually. Sets are designed for a specific plate and screw combination. They are sold Non-Sterilized by the facility according to a validated and monitored hospital or facility protocol prior to use. All plates, screws and wires are made from 316L stainless steel that meets ASTM F138 Standard Specification for Wrought 18-Chromium-14Nickel-2.5 Molybenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 2008. The screws are in various sizes of Cancellous, Cortex, Cannulated, Locking and Headless Compression. Inclinal, LLC's Orthopedic Fixation System (OFS) of plates, screws and wires are single use only.