510(k) Clearance for Pediatric Tibial Intramedullary Fixation Rod

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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a pediatric tibial intramedullary fixation rod.

According to the 510(k) summary document, the device is “intended as a temporary implant for alignment, stabilization and fixation of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained fracture due to trauma or disease.” The “patient population is pediatric, including child and adolescent subgroups, and small-stature adults—such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.” Additionally, “nail lengths greater than 400mm are for skeletally mature patients.”