Device Dossier

Fixation device, internal, nail, intramedullary, femur

Device Dossier for Fixation device, internal, nail, intramedullary, femur (Fixation device, internal, nail, intramedullary, femur, Class IIb, sponsor…

Intended purpose

A solid or cannulated rod made of metal (stainless steel or titanium) or other material which, when inserted into the intramedullary canal of the femur, acts as an immobilization device to hold ends of a fractured bone in place. The device may also be used to support the bone in the presence of a pathological condition. The device may be a locked (by screws, blades, bolts or pins) or unlocked. There are a number of components to assist fixation of more proximal and distal conditions (i.e. for metaphyseal and certain intraarticular fractures). End caps may also be used to protect the inner thread from tissue ingrowth.

TGA Public Summary