OrthoPediatrics receives FDA 510(k) clearance for PediFoot system.
OrthoPediatrics announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its new PediFoot Deformity Correction System, the first pediatric-specific system to treat fractures and deformities of the foot and ankle. This system consists of innovative implants and instrumentation that increase procedure throughput. PediFoot is the first OrthoPediatrics' system to incorporate the StarLoc variable angle locking technology, while also being the thinnest plates in the portfolio. OrthoPediatrics' PediFoot Deformity Correction System is intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, including hands, wrists, feet, and ankles. Common pediatric deformities that this system addresses include cavus foot, flatfoot, clubfoot, and hallux valgus.