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The ODi TALON™ Long Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi TALON™ Long Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts: - A femoral nail with portals that allow passage of distal cortical screws and a proximal lag screw assembly. - The TALON™ Lag Screw used in the nail system is completely compatible with ODi's TALON™ Compression Hip Screw system and has been previously approved by the FDA in K984331. The TALON™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments. - A slotted sleeve which passes through the intramedullary nail. The sleeve is keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw. - A sleeve lock which passes through the proximal end inner bore of the intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly. - A compression screw which shoulders against the slotted sleeve and engages the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The cortical screws have been previously approved by the FDA in K984331. - An end cap with both internal and external threads and a keying slot. The external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation. - Cortical screws are provided to cross-lock the distal end of the nail to the femoral shaft to help prevent axial translation or rotation of the nail. The cortical screws have been previously approved by the FDA in K984331. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery. ODi will manufacture the implants from implant grade stainless steels.