OrthoPediatrics Gains FDA Clearance for PediFoot Deformity Correction

By Julie A. Vetalice

OrthoPediatrics received FDA 510(k) clearance to market the PediFoot Deformity Correction system, reportedly the first pediatric-specific system to treat foot/ankle fractures and deformities. The system will launch in 3Q19.

PediFoot is indicated for fracture fixation, 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.

PediFoot employs the StarLoc™ variable angle locking technology sublicensed earlier this year from CoorsTek Medical (now a UnitedCoatings company). The star-shaped screw head provides five points of fixation between the screw and the corresponding plate.

Source: OrthoPediatrics Corp.

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory