OrthoPediatrics Announces FDA 510(k) Clearance of PNP | Femur Retrograde Nail System and Completes First Implantations
Key Highlights
- ➤FDA clears PNP Femur Retrograde Nail System for pediatric orthopedic use
- ➤First PNP Retrograde surgical procedures successfully completed
- ➤Limited market release planned through 2026; broader commercialization targeted for 2027
- ➤PNP platform has supported nearly 15,000 patients worldwide
Expert Statements
Joe Hauser, Executive at OrthoPediatrics
“Our Pediatric Nailing Platform has supported nearly 15,000 patients worldwide, demonstrating the impact of our differentiated approach to pediatric orthopedic care.”
Joe Hauser, Executive at OrthoPediatrics
“The FDA clearance of PNP Retrograde expands our portfolio and creates an opportunity to reach more children with implants designed specifically for their needs.”
Joe Hauser, Executive at OrthoPediatrics
“With the first surgical case already complete, we are encouraged by the initial adoption of this latest addition to our platform.”
Joe Hauser, Executive at OrthoPediatrics
“By addressing the unique anatomical needs of growing children that adult-focused systems may not fully accommodate, we continue to strengthen OrthoPediatrics’ position as a leader in pediatric-specific orthopedic solutions.”
WARSAW, Ind., Oct. 27, 2026 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. ("OrthoPediatrics" or the "Company") (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced U.S. Food and Drug Administration (FDA) clearance of the Pediatric Nailing Platform (PNP) | Femur Retrograde Nail System (“PNP Retrograde”) and the successful completion of the first procedures using the system.
Developed in collaboration with a team of pediatric orthopedic surgeons, the system was designed specifically for pediatric anatomy to address an important unmet market need and includes anatomic nails for trauma and straight nails for deformity. PNP Retrograde builds on the Company's successful previous launches of PNP Femur and PNP Tibia and leverages existing PNP instrumentation. The new system offers innovative instruments intended to help simplify complex varus/valgus and coronal/sagittal plane correction procedures.
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