Eleganz IM Threaded Nail System (IM Threaded Nail System)

The Eleganz IM Threaded Nail System is a bone fixation device consisting of threaded nails made from 316L stainless steel (11-75 mm length) and associated instruments for nail site preparation and delivery. It is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones such as scaphoid and carpal bones, with specific applications including metacarpal and phalangeal fusions and bunionectomies.

The nails feature similar technological characteristics in design, material, and principle of operation to the predicate devices (Acutrak 3, Mini Cannulated Screw, and Innate Intramedullary Threaded Nail System). The device is made from 316L stainless steel and includes cannulated drills and driver components, with a countersink featuring cutting flutes for ease of nail entry into the intramedullary canal.

Testing was performed per the FDA's Guidance document 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway' (issued November 22, 2024). Biocompatibility evaluation leveraged equivalence in materials and manufacturing to previously cleared devices.

The Eleganz IM Threaded Nail System is substantially equivalent to its predicates (Acutrak 3 Headless Compression Screw System, Mini Cannulated Titanium Screw Set, and Innate Intramedullary Threaded Nail System) because it shares identical indications for use, similar technological characteristics in design and material composition, and demonstrated equivalent performance and biocompatibility through testing and biocompatibility evaluation.