OrthoPediatrics lands FDA clearance for surgical system
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Warsaw-based OrthoPediatrics Corp. has cleared a key hurdle for one of its newest products. The medical device manufacturer has received U.S. Food and Drug Administration clearance for its Pediatric Nailing Platform | Tibia surgical system.
The PNP Tibia system is design to support the treatment of pediatric patients with fractures and deformities in the lower extremities. It includes rigid cannulated nails and specialized instrumentation to facilitate multiple surgical techniques, the company said in a news release.
“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,” Joe Hauser, president of OrthoPediatrics’ Trauma & Deformity Correction business said.
OrthoPediatrics expects to launch the system to surgical providers later this quarter now that it has received FDA clearance.
The company said the PNP Tibia system marks the 51st it has designed specifically to treat the needs of pediatric patients.