FDA OKs OrthoPediatrics’ PNP Tibia Surgical System

OrthoPediatrics has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Pediatric Nailing Platform | Tibia (PNP Tibia) surgical system.
 
PNP Tibia is a pediatric-focused solution comprised of 7-12 mm diameter rigid, cannulated nails to treat patients with lower extremity fractures and deformities. It also includes specialized instrumentation to facilitate various surgical techniques.
 
The PNP Tibia FDA nod expands OrthoPediatrics’ offering to 51 unique surgical systems designed specifically for pediatric patients. The company said PNP Tibia is expected to launch in Q3 2023.
 
“We are pleased with the FDA 510(k) clearance for our new PNP Tibia System, which allows physicians to better treat children with implants and instruments that are made for their unique anatomy and musculoskeletal conditions,” Joe Hauser, president of OrthoPediatrics’ Trauma & Deformity Correction business told the press. “Our engineering team developed this first of its kind system in close collaboration with a group of renown surgeons to address the most common challenges they face in tibial trauma and deformity cases. The PNP Tibia System expands our Pediatric Nailing Platform, which has quickly become the market leader and is our largest trauma product. We are excited by its growth prospects and to bring yet another system to market in our effort to surround our surgeon customers with everything they need to help KIDS.”
 
OrthoPediatrics also completed the first clinical case using its new GIRO Growth Modulation System and began a limited market release of the product in June 2023.