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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.