Regulatory

FDA Approves OrthoPediatrics’ 3P Small Mini System

The versatile plate and screw solution supports a wide range of trauma and deformity surgeries.

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By: Michael Barbella

Managing Editor

OrthoPediatrics Corp. has earned U.S. Food and Drug Administration (FDA) approval for its 3P Pediatric Plating Platform Small-Mini System, the second of several systems in the 3P family. The FDA authorization is the company’s sixth this year.

“This milestone represents another significant step forward in the 3P product development journey,” OrthoPediatrics President of Trauma, Deformity Correction and OPSB Joe Hauser commented. “Our engineering and surgeon design teams continue to demonstrate exceptional work in advancing the next 3P system following the successful launch of 3P Hip. This platform is redefining how pediatric surgeons treat their patients, addressing a significant unmet medical need, and we are excited to move toward a limited market release in early 2026.”

The 3P Small-Mini System is a versatile plate and screw solution featuring variable-angle locking implants designed specifically for pediatric orthopedic surgeons. It supports a wide range of trauma and deformity surgeries with procedure-specific and utility plates in sizes 2 mm, 2.4 mm, 2.7 mm, and 3.5 mm. Featuring specialized instruments, streamlined tray layouts, and color-coding for enhanced surgical flow, the system aims to optimize operating room efficiency.

“We remain focused on delivering a comprehensive portfolio of innovative orthopedic solutions to expand our support to more pediatric patients,” OrthoPediatrics CEO David Bailey said. “This is the sixth FDA approval for the company in 2025, and was received ahead of our expectations, thanks to our R&D team. I’m proud of their work and look forward to continuing to develop not only the 3P platform but our larger portfolio with even more products in the near future.”

Founded in 2006, OrthoPediatrics is focused exclusively on advancing pediatric orthopedics. As such, it has developed a comprehensive product offering to the pediatric orthopedic market with more than 80 products that serve three of the largest categories within the sector. 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 more than 70 countries outside the United States.

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