ARIX Femur Nail System

The ARIX Femur Nail System is an intramedullary fixation device made of titanium alloy used to treat stable and unstable fractures and correct bone deformities in the femur (thighbone), including in the intracapsular, trochanteric, subtrochanteric, and shaft regions. It is indicated for use in osteoporotic and osteopenic bone and is provided in sterile or non-sterile configurations.

The device comprises a nail, lag screw, interlocking screw, set screw, and end cap, all manufactured from titanium alloy meeting ASTM F136. No significant differences exist between the subject device and predicate devices in shape, configuration, design, materials, surface treatment, sterilization, biocompatibility, or performance characteristics.

ASTM F1264-16 (intramedullary fixation device bending and torsional testing), ASTM F384-17 (metallic angled orthopedic fracture fixation static and fatigue testing), ASTM F543-23 (metallic medical bone screw torsional strength, driving torque, and axial pull-out testing), and custom cut-out performance testing.

The ARIX Femur Nail System is substantially equivalent because it shares identical intended use (treatment of femoral fractures and deformities) and equivalent technological characteristics with the predicate Gamma3 System. Bench testing demonstrated the device meets all applicable ASTM performance standards with results equivalent to the predicate device, establishing safety and effectiveness without requiring clinical studies, thereby satisfying the substantial equivalence pathway under 510(k).