OrthoPediatrics Corp. Receives FDA approval for 3P™ Pediatric Plating Platform™ Small-Mini System, the second of several systems in the 3P family
OrthoPediatrics (Nasdaq: KIDS) announced FDA approval of the 3P Pediatric Plating Platform Small-Mini System on October 28, 2025, the company’s 6th FDA approval in 2025. The system is a variable-angle locking plate-and-screw solution for pediatric trauma and deformity surgeries with procedure-specific and utility plates in 2.0mm, 2.4mm, 2.7mm, and 3.5mm sizes.
Features include specialized instruments, streamlined tray layouts, and color-coding to enhance operating room efficiency. The Small-Mini System follows the 3P Hip System and is slated for a limited market release in early 2026.
OrthoPediatrics (Nasdaq: KIDS) ha annunciato l'approvazione da parte della FDA del 3P Pediatric Plating Platform Small-Mini System il 28 ottobre 2025, la 6ª approvazione FDA nel 2025 dell'azienda. Il sistema è una soluzione di piastra e viti a angolo variabile per traumi pediatrici e deformità chirurgiche, con piastre specifiche per procedura e utilità in 2,0 mm, 2,4 mm, 2,7 mm e 3,5 mm di dimensione.
Le caratteristiche includono strumenti specializzati, layout di vassoi semplificati e codifica a colori per migliorare l'efficienza in sala operatoria. Il Small-Mini System segue il 3P Hip System ed è previsto un rilascio limitato sul mercato all'inizio del 2026.
OrthoPediatrics (Nasdaq: KIDS) anunció la aprobación de la FDA del Sistema Small-Mini de Plataforma de Fijación 3P Pediátrica el 28 de octubre de 2025, la 6ª aprobación de la FDA en 2025 de la empresa. El sistema es una solución de placa y tornillo de ángulo variable para traumatología pediátrica y cirugías de deformidad con placas específicas de procedimiento y de utilidad en tamaños 2.0mm, 2.4mm, 2.7mm y 3.5mm.
Entre sus características se incluyen instrumentos especializados, diseños de bandejas optimizados y codificación por colores para mejorar la eficiencia en la sala de operaciones. El Small-Mini System sigue al 3P Hip System y está previsto un lanzamiento limitado al mercado a principios de 2026.
OrthoPediatrics (Nasdaq: KIDS)는 2025년 10월 28일 3P Pediatric Plating Platform Small-Mini System의 FDA 승인을 발표했으며, 이는 회사의 2025년 6번째 FDA 승인이다. 이 시스템은 수술 절차별 및 유틸리티 플레이트를 갖춘 소아 트라우마 및 기형 수술용 가변 각도 록킹 플레이트-나사 솔루션으로, 2.0mm, 2.4mm, 2.7mm, 3.5mm 사이즈로 제작되었다.
특수 도구, 간소화된 트레이 구성, 색상 코딩 등의 기능으로 수술실 효율성을 향상시키며, Small-Mini System은 3P Hip System을 잇따라 선보이고 2026년 초 한정 출시될 예정이다.
OrthoPediatrics (Nasdaq: KIDS) a annoncé l'approbation de la FDA du 3P Pediatric Plating Platform Small-Mini System le 28 octobre 2025, la 6e approbation FDA de l'entreprise en 2025. Le système est une solution de plaque et vis à angle variable pour les traumatismes pédiatriques et les déformations chirurgicales, avec des plaques spécifiques à la procédure et utilitaires en tailles 2,0 mm, 2,4 mm, 2,7 mm et 3,5 mm.
Les caractéristiques incluent des instruments spécialisés, des agencements de plateaux simplifiés et un codage par couleur pour améliorer l'efficacité de la salle d'opération. Le Small-Mini System suit le 3P Hip System et devrait connaître une sortie limitée sur le marché au début de 2026.
OrthoPediatrics (Nasdaq: KIDS) gab die FDA-Zulassung des 3P Pediatric Plating Platform Small-Mini System am 28. Oktober 2025 bekannt, der 6. FDA-Zulassung des Unternehmens im Jahr 2025. Das System ist eine variable Winkel Verankerung Platte-und-Schrauben-Lösung für pädiatrische Traumata und Deformitätseingriffe mit prosternspezifischen und Utilities-Platten in Größen von 2,0 mm, 2,4 mm, 2,7 mm und 3,5 mm.
Zu den Merkmalen gehören spezialisierte Instrumente, vereinfachte Schalen-/Tray-Layouts und Farbcodierung zur Steigerung der Effizienz im Operationssaal. Das Small-Mini System folgt dem 3P Hip System und soll voraussichtlich im frühen 2026 einen Limited Market Release erhalten.
OrthoPediatrics (Nasdaq: KIDS) أعلنت موافقة FDA على 3P Pediatric Plating Platform Small-Mini System في 28 أكتوبر 2025، وهي الموافقة السادسة للشركة من FDA في 2025. النظام هو حل صفيحة ومسامير ذات زوايا قابلة للضبط لإصابات الأطفال وجراحات تشوهات مع صفائح خاصة للإجراءات وصالحة للاستخدام في أحجام 2.0mm و2.4mm و2.7mm و3.5mm.
تشمل الميزات أدوات متخصصة، وتخطيطات صينية مبسطة، وتلوين بالألوان لتعزيز كفاءة غرفة العمليات. يتبع Small-Mini System لـ 3P Hip System وسيتم إطلاق محدود في السوق في بدايات 2026.
OrthoPediatrics (Nasdaq: KIDS) 于2025年10月28日宣布获得FDA批准的3P Pediatric Plating Platform Small-Mini System，这是该公司在2025年的第6 个 FDA 批准。该系统是一种用于儿科创伤和畸形手术的变角度锁定板螺钉解决方案，具有专用程序板和实用板，尺寸为2.0mm、2.4mm、2.7mm 和 3.5mm。
其特征包括专用工具、简化的托盘布局和颜色编码，以提高手术室效率。Small-Mini System紧随3P Hip System，并计划在2026年初进行有限市场发布。
- 6th FDA approval for the company in 2025
- System supports trauma and deformity surgeries across four plate sizes
- Designed to improve operating room efficiency with instruments and color-coding
- Planned limited market release in early 2026
- None.
Insights
FDA cleared a pediatric plating system; expands surgical options and supports a limited market release expected in
The approval of the 3P™ Pediatric Plating Platform™ Small-Mini System adds a variable-angle plate-and-screw solution sized for pediatric anatomy in 2.0mm, 2.4mm, 2.7mm, and 3.5mm. This system targets trauma and deformity procedures and includes procedure-specific plates, specialized instruments, streamlined trays, and color-coding designed to improve operating-room efficiency and surgical workflow.
Primary dependencies include surgeon adoption, inventory rollout, and the limited market release timing stated for
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 6th FDA 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 6th FDA 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.”
About OrthoPediatrics Corp.
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 visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.
Investor Contact
Philip Trip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937- 5406
FAQ
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