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The Atlas™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including: - · Diaphyseal fractures of the humeral shaft - · Proximal humeral fractures with diaphyseal extension - · Impending pathologic fractures

The Atlas™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts: . A humeral nail with proximal portals for passage of cortical locking screws and/or Atlas™ Screws. The humeral nail also has distal portals that allow passage of deployable integral talons from within the intramedulary canal. The distal talons may be retracted for removal of the nail is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed. · Cortical locking screws will be provided separately. The cortical locking screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired. · Atlas™ Screws will be provided separately. The Atlas™ Screws have distal portals that allow the passage of integral talons that can be deployed for additional fixation and stability. · A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. The proximal end cap also comes in a locking version which includes a distal shaft that locks the cortical locking screw or Atlas™ screw placed in the most proximal portal. ODI-NA will manufacture the implant grade titanium alloy (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts: - A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths. - A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected. ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including: • Diaphyseal fractures of the humeral shaft - · Proximal humeral fractures with diaphyseal extension - · Impending pathologic fractures

The Talon™ DistalFix™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts: - A humeral nail with proximal portals for passage of cortical locking screws ● and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed. - Cortical locking screws will be provided separately. The cortical locking . screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired. - A proximal end cap will be provided separately. The end cap prevents ● bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. ODi-NA will manufacture the implants from implant grade titanium alloy.

The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including: - · Femoral shaft fractures - · Ipsilateral femur fractures - · Supracondylar fractures, including those with intra-articular extension - · Osteoporotic fractures - · Pathologic/impending pathologic fractures - · Malunions/nonunions The device is intended to stabilize fragments of the fracture until bony union can occur.

The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is used for fixation and stabilization of fractures of the femur until bony union can occur. The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail may be inserted into the femoral canal using either an antegrade or retrograde surgical approach. The system consists of the following parts: - A femoral nail with proximal portals for passage of cortical locking screws and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed. - Cortical locking screws will be provided separately. The cortical locking screws are provided for proximal fixation if desired. - Universal cortical locking screws will be provided separately. The universal cortical locking screws provide increased purchase in cancellous bone and are provided for proximal fixation if desired. - A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. ODi-NA will manufacture the implants from implant grade titanium alloy.

The Talon™ DistalFix™ Proximal Femoral Nail's primary indications are for the fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The Talon™ DistalFix™ 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 a proximal portal for passage of a lag screw and distal portals that allow passage of deployable intearal talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons, distal end cap and integral lock screw subassembly already installed. - . A Talon™ lag screw with proximal portals for passage of deployable talons to increase the purchase of the lag screw within the femoral neck/head. These talons may also be retracted for removal of the lag screw if and when it is necessary. The lag screw is cannulated and keyed with tapered flats on the distal This keyed shaft allows the option of static, compression, or axial end. - A proximal end cap will be provided separately. The end cap prevents bony . ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. ODi-NA will manufacture the implants from implant grade titanium allov.