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…
- GMDN category: Fixation device, internal, nail, intramedullary, femur
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.