OrthoPediatrics Receives FDA Designation

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Warsaw-based OrthoPediatrics Corp. (Nasdaq: KIDS) says it has received 510(k) approval from the U.S. Food and Drug Administration for its sterile-packed implants for the Pediatric Nailing Platform | FEMUR system.

Having received the approval, the orthopedic device maker can now launch the use of the system on a limited basis in the U.S.

The company says the device was designed to repair a variety of deformities and fractures in the thighbone of pediatric patients

OrthoPediatrics says the system is now available in four countries and has been used to treat over 1,000 children since its launch in 2018.