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.
OrthoPediatrics Announces FDA 510(k) Clearance of PNP | Femur Retrograde Nail System and Completes First Implantations
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FDA 510(k) clearancePediatric Nailing PlatformOrthoPediatrics Corporationpediatric orthpedicsFemur Retrograde Nail 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.
"Our Pediatric Nailing Platform has supported nearly 15,000 patients worldwide, demonstrating the impact of our differentiated approach to pediatric orthopedic care," 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. 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."
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.
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets over 95 systems that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 75 countries outside the United States. For more information, please visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.
Investor Contact
Philip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
OrthoPediatrics has strategically expanded its Pediatric Nailing Platform with the FDA-cleared PNP | Femur Retrograde Nail System, targeting an unmet market need in pediatric femoral trauma and deformity. This move strengthens its leadership in pediatric-specific solutions, leveraging existing instrumentation and a proven platform. The phased commercialization, starting with a limited 2026 release, aims for broader market penetration in 2027, enhancing the company's competitive position and market share.
- The new system expands OrthoPediatrics' product portfolio, addressing a specific market gap in pediatric femoral fixation and reinforcing its competitive advantage.
- A phased commercialization strategy (limited 2026, broad 2027) aims to optimize market adoption and revenue growth for this specialized pediatric device.
PhD Lens: Clinical and outcomes impact
The PNP | Femur Retrograde Nail System, developed with pediatric orthopedic surgeons, received FDA 510(k) clearance. It features anatomic nails for trauma and straight nails for deformity, specifically designed for pediatric anatomy. The system leverages existing PNP instrumentation and offers innovative tools to simplify complex varus/valgus and coronal/sagittal plane corrections, building on a platform that has served nearly 15,000 patients.
- The system incorporates anatomic and straight nails, specifically designed for pediatric femoral anatomy to address trauma and deformity correction.
- Innovative instruments are included to facilitate complex coronal and sagittal plane corrections, enhancing surgical precision for pediatric patients.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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