T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

The T2 Alpha Femur Retrograde Nailing System is an intramedullary fixation device intended for temporary stabilization of femoral bone fractures and related conditions including pseudoarthrosis, pathologic fractures, supracondylar fractures, and nonunions. The Pangea Femur Reconstruction System consists of anatomically pre-contoured distal femur plates and interlinking dowels used in combination with the T2 Alpha nails for complex distal femur fractures in normal and osteopenic bone.

The new submission introduces shorter lengths of pre-contoured lateral struts and spanning attachments for the T2 Alpha system, all manufactured from Ti6Al4V ELI with Type II anodization, available in left/right versions and both sterile and non-sterile packaging. The Pangea system rebrands previously cleared distal lateral and medial femur plates, dowels, and spanning attachments for use with existing T2 Alpha nails.

ISO 13485 (design controls, nonconforming product, corrective/preventive action), ISO 10993-1 (biocompatibility), ISO 11607-1 and ISO 11607-2 (packaging), ASTM F897 (fretting corrosion), ASTM F2052 (MR magnetically induced displacement force), ASTM F2213 (MR magnetically induced torque), ASTM F2182 (MR RF-induced heating), and ASTM F2119 (MR image artifacts).

The T2 Alpha and Pangea systems are substantially equivalent to their predicate devices (K250163 and K231262 respectively) in intended use, indications, materials, design, and operational principles. Non-clinical performance testing including construct fatigue strength, cut-out performance, stiffness, bending strength, and fretting corrosion demonstrated equivalence, and the devices raise no new questions of safety and effectiveness.