Fassier-Duval Telescoping IM System

The Fassier-Duval Telescopic IM System is a temporary intramedullary fixation rod designed for pediatric patients with bone fractures, osteotomies, malunions, and nonunions, particularly those with Osteogenesis Imperfecta and other pediatric bone diseases. The telescopic design allows bone lengthening and shortening while preserving the growth plate, and can be used concomitantly with external fixators for limb length discrepancy correction.

The device comprises two sliding components (female and male) that allow extension as bone structures heal while normal patient growth occurs. Anchorage is achieved through screw-type fixation at the proximal-trocanteric cortex and distal cortex. The device is substantially identical to predicates in system components, dimensions, design features, materials, principle of operation, and sterilization characteristics, with no deviations noted.

ASTM F2119-07 (MR Image Artifacts from Passive Implants); ASTM F2052-14 (Magnetically Induced Displacement Force on Medical Devices in MR Environment); ASTM F2213-06 (Magnetically Induced Torque on Medical Devices in MR Environment); ASTM F2182-11a (Radio Frequency Induced Heating Near Passive Implants During MR Imaging). The implants were evaluated for MR conditional use.

The subject device shares identical intended use, principles of operation, patient population, and technical characteristics with the primary predicate (K211292) and reference predicates (K041393, K020885, and K192710). The submission updated indications to include bone diseases beyond Osteogenesis Imperfecta, but this expansion is supported by existing clinical literature demonstrating safe and effective use in these conditions. Since no design changes were made and the device functions identically to predicates already cleared for these applications, the differences do not raise new safety or effectiveness questions.