Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur

The Pediatric Nailing Platform consists of intramedullary nails for stabilizing broken tibias and femurs in pediatric and small-stature adult patients. The tibia nails are made of Ti-6Al-4V ELI and the femur nails are made of 316L stainless steel. Both systems use transverse screws for locking and may include end caps to facilitate removal and prevent bony ingrowth. The devices are intended as temporary implants for fracture fixation, osteotomy correction, and related orthopedic conditions.

The only differences between the subject device and predicate devices are in packaging and sterilization: subject devices are provided sterile with a 5-year shelf life in inner and outer pouches with a shelf carton, while predicates were non-sterile without shelf life in cases and trays. The fundamental design, materials, intended use, patient population, and principles of operation remain identical.

Not stated in this summary.

Substantial equivalence is established through identity of intended use, patient population, principles of operation, and all fundamental technological characteristics with the predicate devices. The subject devices perform the same function—intramedullary fixation with rigid metallic nails and transverse locking screws. Engineering analysis demonstrates no impact of sterilization or aging on device performance. Biocompatibility was assessed for the new packaging materials, and MR safety remains unchanged (MR conditional). The change to sterile packaging with shelf life does not alter the core mechanical or functional characteristics that define the device.