T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

The T2 Alpha Humerus Nailing System is an intramedullary fixation device for treating humerus fractures, including non-unions, malunions, malalignments, and pathological fractures. It consists of sterile titanium alloy nails, end caps, compression screws, and washers used with locking screws to stabilize the fracture. The IMN Screws System provides bone screws inserted through the nail to stabilize the nail-bone construct.

The subject device introduces three new nail diameters (10, 11, and 12 mm) compared to the predicate T2 Nailing System. The advanced locking screws have shorter lengths (Ø4mm – 20, 22.5, and 25 mm). All implants remain single-use, sterile, titanium alloy devices sterilized via gamma irradiation with no change to fundamental operating principles or design philosophy.

Testing included ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF-induced heating), ASTM F2119 (image artifacts), ISO 11607-1 and ISO 11607-2 (packaging), ISO 10993-1 (biocompatibility), and mechanical testing (dynamic/static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force).

Substantial equivalence is established because the subject devices have identical intended use and indications as the predicate devices (T2 Nailing System K032523, Tornier Humeral Nail K230352, IMN Screws System K213328). The devices use the same titanium alloy materials, sterilization methods, and fundamental operating principles. Performance testing demonstrates the new nail diameters and screw lengths maintain mechanical properties comparable to predicate devices, and no differences raise new safety or effectiveness questions. The devices are therefore at least as safe and effective as legally marketed predicates.