OrthoPediatrics Receives FDA Approval for 3P Pediatric Plating Platform Small-Mini System
OrthoPediatrics Corporation, a company dedicated exclusively to pediatric orthopedics, has received U.S. FDA approval for its 3P Pediatric Plating Platform Small-Mini System — the second system in its 3P family. This marks the company’s sixth FDA approval in 2025.
Expanding the 3P Platform
The 3P Small-Mini System is a versatile plate and screw solution designed specifically for pediatric orthopedic surgeons. It features variable-angle locking implants and supports a broad range of trauma and deformity surgeries.
The system includes procedure-specific and utility plates in 2.0 mm, 2.4 mm, 2.7 mm, and 3.5 mm sizes, along with specialized instruments, streamlined tray layouts, and color-coded components to enhance surgical efficiency.
As the second release in the 3P Pediatric Plating Platform, the Small-Mini System follows the 3P Hip System, which the company describes as a successful earlier launch.
Leadership Commentary
“This milestone represents another significant step forward in the 3P product development journey,” said Joe Hauser, President of Trauma, Deformity Correction and OPSB at OrthoPediatrics. “Our engineering and surgeon design teams continue to demonstrate exceptional work following the successful launch of 3P Hip. This innovative platform is redefining how pediatric surgeons treat their patients and addresses a significant unmet need. We are excited to move toward a limited market release in early 2026.”
David Bailey, Chief Executive Officer of OrthoPediatrics, added: “We remain focused on delivering a comprehensive portfolio of innovative orthopedic solutions to expand our support for more pediatric patients. This sixth FDA approval in 2025 was received ahead of expectations, thanks to the dedication of our R&D team. I’m incredibly proud of their work and look forward to further advancing both the 3P platform and our broader product portfolio.”
Company Overview
OrthoPediatrics Corporation develops orthopedic solutions exclusively for pediatric patients. The company markets over 80 products spanning trauma and deformity correction, scoliosis, and sports medicine/other procedures.
Its global sales network operates in the United States and across more than 70 countries worldwide.
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