OrthoPediatrics Wins FDA 510(k) Clearance for PNP Femur Retrograde Nail System: First Procedures Completed, Broader Commercialization in 2027
OrthoPediatrics Corp. (Nasdaq: KIDS), a pediatric orthopedics company based in Warsaw, Indiana, announced on October 27 that the Pediatric Nailing Platform (PNP) | Femur Retrograde Nail System (PNP Retrograde) has received U.S. Food and Drug Administration (FDA) 510(k) clearance, and that the first procedures using the system have been completed.
Developed in collaboration with a team of pediatric orthopedic surgeons, the system was designed specifically for pediatric anatomy to address an unmet market need. It includes anatomic nails for trauma and straight nails for deformity, builds on the company's earlier PNP Femur and PNP Tibia launches, and leverages existing PNP instrumentation. New instruments are intended to help simplify complex varus/valgus and coronal/sagittal plane correction procedures.
“Our Pediatric Nailing Platform has supported nearly 15,000 patients worldwide,” said Joe Hauser. “The FDA clearance of PNP Retrograde expands our portfolio and creates an opportunity to reach more children with implants designed specifically for their needs. With the first surgical case already complete, we are encouraged by the initial adoption of this latest addition to our platform.”
PNP Retrograde is available in diameters ranging from 7 mm to 11 mm in both nail designs. The system will be available through a limited market release for the remainder of 2026, with broader commercialization planned for 2027.
Founded in 2006, OrthoPediatrics focuses exclusively on pediatric orthopedics. It markets more than 95 systems across trauma and deformity, scoliosis, and sports medicine and other procedures, distributed in the United States and more than 75 countries.
Source: GSM · USA (original Chinese edition)
Photo: 股骨髓内钉内固定术后影像（资料图，非本产品、非儿童病例）。Hellerhoff 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Postoperative imaging of femoral intramedullary nail fixation (file photo; not the product in this story and not a pediatric case). Hellerhoff, CC BY-SA 4.0, via Wikimedia Commons.
