PediFlex™ Flexible Nail System

The PediFlex™ Flexible Nail System is an intramedullary nail fixation device made from 316L stainless steel or titanium alloy, designed to repair diaphyseal fractures of long bones with narrow medullary canals or where implant flexibility is needed. It is indicated for upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients, with the flexibility allowing insertion without disturbing growth plates.

The subject device and predicate share identical intended use, patient population, principles of operation, and fundamental technological characteristics. Differences exist in sterilization processing, packaging design, shelf life labeling, and addition of MR conditional labeling, all supported by validation testing. Material options (316L stainless steel and titanium alloy) and component sizes remain functionally equivalent to the predicate.

Sterilization and cleaning validation per AAMI ST72, AAMI ST98, ASTM F3127, ISO 11137-1/2, ISO 11737-1/2/3, and ISO 19227. Package design and shelf life validation per ASTM D4332, D4169, F2096, F2203, F88, F1886, ISO 11607-1/2, and ISO 15415/15416. MR safety evaluation per ASTM F2052, F2213, F2182, F2119, and FDA MR guidance (October 2023). Usability validation per ISO 11607-1 and IEC-62366-1.

The subject device is substantially equivalent because it maintains the same intended use, patient population, design principles, and core technological characteristics as the predicate device (K201838). Although sterilization, packaging, shelf life, and MR conditional labeling differ from the predicate, these differences are non-fundamental and supported by comprehensive validation testing demonstrating no new safety or effectiveness concerns. Biocompatibility was assessed and found acceptable given the identical materials and modified processing flow.