FDA Clears New OrthoPediatrics Device

OrthoPediatrics is a Warsaw-based maker of orthopedic products for children

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Warsaw-based OrthoPediatrics Corp. (Nasdaq: KIDS) says it has received clearance from the U.S. Food and Drug Administration for its new PediFoot Deformity Correction System. The company says “PediFoot” is the first pediatric-specific system to treat fractures and deformities of the foot and ankle in children. The company says it can also be used on hands and wrists.

OrthoPediatrics says the system is intended for repairs of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments.

“As we continue to develop innovative new products, we are working to ensure that pediatric orthopedic surgeons have the right instrumentations needed to treat children with orthopedic conditions,” said OrthoPediatrics’ Vice President Joe Hauser. “This system closes a gap in the marketplace and our portfolio, providing surgeons with novel technologies to treat four of the most common pediatric foot deformities.”

The company says one of the most common pediatric deformities are cavus foot, flatfoot and clubfoot.

It plans to launch the system in the third quarter.