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510(k) Data Aggregation
(266 days)
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(76 days)
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.
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(17 days)
The Affixus Natural Nail Humeral Nail System nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.
The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:
- Proximal fractures (proximal short and long nails only)
- Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only)
- Open and closed fractures
- Comminuted fractures
- Nonunions and malunions
- Pathologic fractures
The Affixus® Natural Nail® Humeral Nail System consists of temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. The nail restore the shape of intramedullary bone, and they are available in a variety of lengths and diameters to meet assorted patient needs. The humeral nails are used together with Bone Screws, Washers, and Nail Caps. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass-through holes in the nail. A locking mechanism feature (CoreLock™) within the Proximal Humeral Nails provides the option to lock 4.0 mm diameter Blunt Tip Screws within the nail. CoreLock™ secures the screws against medial or lateral migration. The current design locks on the outer thread diameter of the screw, relying on friction. The Proximal Humeral Nails are made of Titanium alloy [Protasul®-64WF (Ti-6Al-4V) ISO 5832-3/ASTM F136] and C.P Titanium [Protasul®-Ti SO 5832-2/ASTM F67].
The reason for this submission is to introduce a design change of the CoreLock™ locking system in the Affixus® Natural Nail® Humeral Nails by replacing the teeth profile with a multiple thread pitch. The new design preserves the friction fit mechanism and adds a form-fit interaction for enhanced locking performance.
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(96 days)
ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
Anti-Rotation Lag Screw and Telescopic Lag Screw in ARIX Femur Nail System are made of Titanium Alloy which meets ASTM F136 and only 'Anti-Rotation Pin' section of Anti-Rotation Lag Screw is made of Nickel-Titanium Alloy which meets ASTM F2063. ARIX Femur Nail System is provided Sterile or Non-Sterile.
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