OrthoPediatrics cleared the PNP Femur Retrograde Nail System and has already completed its first cases. The Warsaw, Indiana company announced the 510(k) on October 27. Nails come in diameters from 7 mm to 11 mm.
The system ships in two designs: anatomic nails for trauma and straight nails for deformity correction. It runs on existing Pediatric Nailing Platform instrumentation, with added instruments meant to simplify varus and valgus correction and work in the coronal and sagittal planes. A limited market release runs through the rest of 2026, with broader commercialization planned for 2027.
The company says the Pediatric Nailing Platform has supported nearly 15,000 patients worldwide, after earlier PNP Femur and PNP Tibia launches. OrthoPediatrics markets more than 95 systems and sells in the US and more than 75 other countries.
The clearance arrived with third quarter results the same day: revenue of $72.7 million, up 19 percent from $61.2 million a year earlier, and full-year guidance raised to a range of $270.0 million to $273.0 million. Shipping a limited release in the quarter you raise guidance is a tidy sequencing trick, and it only works when the instrument set already sits in the hospital.