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

The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

TGA Public Summary