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OrthoPediatrics Corp. Receives FDA approval for 3P™ Pediatric Plating Platform™ Small-Mini System, the second of several systems in the 3P family

Key Takeaway: OrthoPediatrics Corp. has received FDA approval for its 3P Pediatric Plating Platform Small-Mini System, marking the company's sixth approval in 2025. This system is designed for pediatric orthopedic surgeries and features variable-angle locking implants. The approval follows the successful launch of the 3P Hip System and aims to enhance surgical efficiency. A limited market release is expected in early 2026.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval represents significant progress for OrthoPediatrics.
  • The 3P Small-Mini System addresses unmet medical needs in pediatric surgery.
  • The company has achieved six FDA approvals in 2025, indicating strong innovation.

Full Press Release Details

WARSAW, Ind., Oct. 28, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the FDA approval of its 3P™ Pediatric Plating Platform™ Small-Mini System, the second of several systems in the 3P family. This represents the company’s 6thFDA approval in 2025.
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 2.0mm, 2.4mm, 2.7mm, and 3.5mm. Featuring specialized instruments, streamlined tray layouts, and color-coding for enhanced surgical flow, the system aims to optimize operating room efficiency. As the second release in the 3P Pediatric Plating Platform, it follows the highly successful 3P Hip System.
OrthoPediatrics President of Trauma, Deformity Correction and OPSB, Joe Hauser commented, “This milestone represents another significant step forward in the 3P product development journey. 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 innovative 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.”
CEO, David Bailey echoed those comments, saying “We remain focused on delivering a comprehensive portfolio of innovative orthopedic solutions to expand our support to more pediatric patients. This is the 6thFDA approval for the company in 2025, and was received ahead of our expectations, thanks to the dedication and excellence of our R&D team. I’m incredibly proud of their work and look forward to continuing to develop not only the 3P platform but our larger portfolio with even more groundbreaking products in the near future.”

AboutOrthoPediatricsCorp.

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 80 products 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 70 countries outside the United States. For more information, please visitwww.orthopediatrics.com.For more information about the OrthoPediatrics Specialty Bracing portfolio, please visitwww.opsb.com.

Investor ContactPhilip Trip TaylorGilmartin Groupphilip@gilmartinir.com415-937- 5406

Frequently Asked Questions

What is the 3P Pediatric Plating Platform?

The 3P Pediatric Plating Platform is a versatile plate and screw solution for pediatric orthopedic surgeries.

How many FDA approvals has OrthoPediatrics received in 2025?

OrthoPediatrics has received six FDA approvals in 2025.

When is the limited market release of the new system?

The limited market release of the 3P Small-Mini System is expected in early 2026.

What features enhance the 3P Small-Mini System?

The system features variable-angle locking implants and specialized instruments for improved surgical flow.

Last updated: Oct 28, 2025