T2 Alpha Femur Retrograde Nailing System

The T2 Alpha Femur Retrograde Nailing System is an intramedullary fixation device consisting of anatomically pre-contoured struts and interlinking dowels used with existing femoral nails to treat complex distal femur fractures. It is designed for open and closed femoral fractures, pseudoarthrosis, pathologic fractures, supracondylar fractures, and other femoral fracture types. The struts must be used only with the nails of this system and cannot be used as stand-alone devices.

The struts are manufactured from Ti6Al4V ELI with Type II anodization in various sizes and left/right versions, available in sterile and non-sterile packaging. The interlinking dowels are made of CoCr and provided sterile. The subject devices utilize the same nails and screws as the primary predicate device for fracture fixation and are intended for use as a linked construct with an intramedullary nail, identical to the predicate design.

ISO 10993-1 (biocompatibility), ISO 11607-1 and ISO 11607-2 (packaging), ASTM F897 (fretting corrosion), ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (MR image artifacts).

The subject devices have identical intended use and indications as the predicate device (T2 Alpha Femur Retrograde Nailing System K203819). Both use the same fundamental scientific technology and materials (Ti6Al4V), with the only difference being dowels made of CoCr instead of Ti6Al4V. Non-clinical bench testing demonstrated equivalent performance in fatigue strength, cut-out performance, stiffness, shear/pull-out, bending, corrosion, and MR safety. Because the devices share the same operating principle, nails, screws, and sterilization method, and performance testing shows no differences that raise different safety or effectiveness questions, substantial equivalence is established.