OrthoPediatrics’ Foot Deformity Treatment Earns 510(k) Clearance
The FDA has granted OrthoPediatrics 510(k) clearance for PediFoot, a pediatric-specific system for treating foot and ankle fractures and deformities.
The device is intended for fixating fractures, osteotomies, non-unions, replantations, and small bone and bone fragment fusions in pediatric patients, including the feet, ankles, hands and wrists. It uses the company’s variable angle locking technology, which offers five points of fixation.
PediFoot addresses common deformities encountered in pediatric patients, including cavus foot, flatfoot, clubfoot and hallux valgus, the company said.