OrthoPediatrics (NSDQ:KIDS) today said it received FDA 510(k) clearance and launched its first sterile-packed implants for the Pediatric Nailing Platform Femur.
The system is designed for use in pediatric patients to address femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions, malunions and fixation of femurs that have been prepared for deformity correction.
“The introduction of sterile implants represents an important addition to our portfolio of sterile implant offerings,” VP of trauma and deformity correction Joe Hauser said in a news release. “We are committed to adding sterile implants to the systems that can provide real value to our customers. We are strategically aligned with our customers to decrease the overall footprint of all our systems while balancing and ensuring intraoperative efficiency.”
OrthoPediatrics’s Pediatric Nailing Platform is available in four countries and will help hospitals improve patient safety and better trace implant use while lowering sterile processing departments’ turnover burden and costs, according to the company.