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OrthoPediatrics Announces FDA 510(k) Clearance of PNP | Femur Retrograde Nail System and Completes First Implantations

KIDS
  • OrthoPediatrics Corp. (NASDAQ: KIDS) received FDA clearance for the Pediatric Nailing Platform (PNP) | Femur Retrograde Nail System ("PNP Retrograde").
  • The company reported the successful completion of the first surgical procedures using the new system.
  • PNP Retrograde was developed with pediatric orthopedic surgeons to address unmet market needs, featuring anatomic nails for trauma & straight nails for deformity.
  • The new system leverages existing PNP instrumentation & includes innovative instruments to simplify complex varus/valgus & coronal/sagittal plane corrections.
  • CEO Joe Hauser stated the broader PNP portfolio has supported nearly 15,000 patients worldwide.
  • PNP Retrograde is available in diameters ranging from 7 mm to 11 mm.
  • The system will undergo a limited market release for the remainder of 2026 with broader commercialization planned for 2027.
  • OrthoPediatrics currently markets over 95 systems across trauma, deformity, scoliosis, & sports medicine categories.
  • The company distributes products in the U.S. & over 75 countries outside the U.S.