
OrthoPediatrics Launches Pediatric Nailing Platform for Tibial Fractures
OrthoPediatrics Corp. has announced today it has released the new Pediatric Nailing Platform TIBIA system and successfully completed the first cases in its limited launch. The Company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in September 2023.
Pediatric tibial fractures are the third most common pediatric long bone fracture after the femur and forearm, representing 15% of all pediatric fractures. There are approximately 900,000 pediatric fracture cases treated annually in the United States and consequently there are about 135,000 tibial fractures every year. Intramedullary nailing is a widely utilized method for treating tibial shaft fractures, favored for its minimal surgical dissection, which preserves the blood supply by avoiding significant disruption of soft tissue surrounding the fracture. This method offers biomechanical stabilization using a load-sharing device, enabling early postoperative ambulation while minimizing disruption to soft tissues.
Part of the Trauma & Deformity Correction suite of products, PNP Tibia represents another pediatric-focused solution for treating patients with fractures and deformities in the lower extremities. It expands the Company’s offering to 52 unique systems designed specifically to help treat the needs of pediatric patients. The PNP Tibia System features rigid cannulated nails, ranging in diameters from 7mm-12mm, and includes specialized instrumentation to facilitate multiple surgical techniques. Like other OrthoPediatrics products, this system was designed for children’s anatomy and growing patients.
Joe Hauser, President of OrthoPediatrics’ Trauma & Deformity Correction business stated, “It is extremely gratifying to see the system perform successfully in two unique and challenging cases. It shows the expert surgeon design team hit the mark along with OP engineers to design a system that will help many kids in the years to come.”