Search Results

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.

N/A

Ask a specific question about this device