The U.S. Food and Drug Administration granted a 510(k) clearance to OrthoPediatrics Corp.'s Pediatric Nailing Platform FEMUR, a surgical system.
The system is an upgrade of the company's Intramedullary Nailing franchise.
An intramedullary nail is a metal rod forced into the central cavity of bone shafts. These nails are used to treat fractures of long bones of the body.
Luis Vega, the company's engineering director of Trauma and Deformity Correction, said the new platform will allow surgeons to treat a wider range of children and pathologies and serve as a base for intramedullary nailing endeavors.
Warsaw, Ind.-based OrthoPediatrics designs, develops and sells orthopedic implants for children.
