Warsaw, Indiana-based OrthoPediatrics Corp. is expanding to the United Kingdom with two of its pediatric surgical systems after receiving the necessary regulatory clearance.
Founded in 2006, the pediatric orthopedics company provides its products in the United States and to 43 countries globally. Its product portfolio includes 35 surgical systems focused on trauma and deformity, scoliosis, and sports medicine. OrthoPediatrics has introduced two of these systems to the United Kingdom, the Pediatric Nailing Platform | FEMUR (PNP|FEMUR) and ApiFix.
OrthoPediatrics has received regulatory clearance in the United Kingdom for PNP|FEMUR. PNP|FEMUR is used “to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomies) for correction of deformity.” Designed for the pediatric-specific anatomy, the system offers both child and adolescent nail ranges.
OrthoPediatrics has also begun the clinical use of ApiFix in the United Kingdom, a system OrthoPediatrics just acquired last year. According to its website, “ApiFix’s Minimally Invasive Deformity Correction (MID-C) System is a posterior dynamic deformity correction system device that enables surgeons to perform a novel surgical treatment providing permanent curve correction while retaining spine flexibility with a least invasive approach.”
Designed for young patients with progressive scoliosis, the ApiFix device is implanted in a procedure where patients can be discharged within one to two days and can return to school within one to two weeks. The MID-C System has both U.S. Food and Drug Administration and CE Mark approvals.
OrthoPediatrics President Dave Bailey commented, “Our continued international expansion represents our commitment to being the end-to-end provider of pediatric orthopedics solutions around the globe.”
For OTW’s recent coverage of OrthoPediatrics, see “OrthoPediatrics Acquires ApiFix,” “OrthoPediatrics Named Best Place to Work in Indiana,” and “OrthoPediatrics Sells Vilex Adult Device Business.”
