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

Intended for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

TGA Public Summary