Regulatory

FDA Okays OrthoPediatrics’ 3P Pediatric Plating Platform Hip System

Product is a new plate and screw platform to modernize trauma and deformity correction treatment in the lower extremities.

OrthoPediatrics Corp. has won its fifth U.S. Food and Drug Administration (FDA) approval this year, gaining the agency’s blessing for the 3P Pediatric Plating Platform Hip System.

Further expanding the company’s Trauma and Deformity portfolio, the 3P Pediatric Hip System is a new plate and screw platform to modernize trauma and deformity correction treatment in the lower extremities. This family of plating systems provides surgeons unparalleled coverage for various trauma and deformity correcting indications by delivering unique implants and instruments to improve surgical workflow and inventory efficiency.  

“The 3P Pediatric Plating Platform is a system with significant opportunity to fill unmet needs,” OrthoPediatrics Trauma and Deformity Division President Joe Hauser said. “This family of systems is one of the largest product endeavors that we’ve taken on within the Trauma and Deformity side in company history, and we are excited for 3P Hip to be the first step to further share-taking opportunities within the plating franchise.”

The beta launch for 3P Hip is expected to be followed by the next system, 3P Small/Mini, early next year, followed by expected future launches of additional systems. Once complete, the company’s plate and screw product portfolio will provide clinicians with the most robust and modern plating portfolio in pediatric orthopedic history, according to the company.

“We continue to focus on providing surgeons with a comprehensive portfolio of innovative orthopedic treatments to address all unmet needs for pediatric patients, and the latest FDA approval for the 3P Hip System marks our fifth FDA approval thus far in 2025,” CEO David Bailey stated. “I’m proud of the work our R&D team has done to achieve this goal and look forward to the addition of many more products in the future as we continue to expand our portfolio.”

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 for children with orthopedic conditions. The company currently markets more than 80 products that serve three of the largest categories within the pediatric orthopedic sector. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization distributes its products in the United States and more than 70 countries worldwide.

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