Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

Inclusion criteria

• Subject, representative willing to sign informed consent.
• Ability and willingness of the subject to follow postoperative care instructions until healing is complete
• Subject age must be between 8-16 inclusive.
• Subjects with a minimal canal diameter of 9mm or greater

And any of the following fracture types

• Non-comminuted and comminuted mid-shaft fractures
• Distal third fractures 4 cm above the distal physis
• Fractures that are open or closed
• Subtrochanteric fractures

Exclusion criteria

• A subject has a bone or soft tissue infection.
• Subject has a systemic infection.
• Subject has a distal (supracondylar) fracture.
• Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
• Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
• Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
• Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.