Search Results

The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. The indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures.
• Non-unions, malunions, and deformities.
• Peri-implant fractures.

When used with the T2 Alpha Femur Retrograde Nailing System, the Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K250163, consists of implants (intramedullary nails in various diameter and sizes, compression screw, end caps, distal lateral/medial struts and interlinking dowels), as well as non-sterile instrumentation.

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of shorter lengths of the pre-contoured lateral struts, and of a spanning attachment to be used together with the existing lateral struts.
The struts and spanning attachments are manufactured from Ti6Al4V ELI (Type II anodization) and are available in left/right versions; these will be provided both non-sterile and sterile packaged.

Additionally, the purpose of this bundled submission is to rebrand some of the devices previously cleared in K250163 under the new Pangea Femur Reconstruction System. This system will consist of the distal lateral and medial femur plates, the dowels and the spanning attachments, as well as non-sterile instruments. The anatomically pre-contoured plates and interlinking dowels of this system will be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

N/A

Ask a specific question about this device