OrthoPediatrics Corp. - FDA 510(k) Cleared Devices

OrthoPediatrics Corp., is a pediatric orthopedic medical device company focused exclusively on children's orthopedic care. Based in Warsaw, Indiana, the company designs and manufactures implants and surgical systems for pediatric trauma, deformity correction, scoliosis, and sports medicine applications.

The company has received 38 FDA 510(k) clearances from 40 total submissions since its first clearance in 2008. 100% of submissions fall within the Orthopedic device category. The latest clearance in 2026 reflects continued regulatory activity and product innovation in pediatric orthopedic solutions.

OrthoPediatrics markets over 70 systems spanning multiple surgical specialties. Recent FDA 510(k) cleared devices include plating platforms for hip and tibia fractures, flexible and rigid nailing systems, spinal growth guidance technology, external fixation systems, and cannulated screw systems. These products address the unique anatomical and physiological needs of growing children.

Explore the company's complete FDA 510(k) clearance history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Orthopediatrics, Inc. as regulatory consultant.