FDA Clears Orthofix’s OrthoNext Digital Platform for the JuniOrtho Plating System

Orthofix Medical Inc. is expanding its pediatric offerings with the U.S. Food and Drug Administration (FDA) 510(k) clearance of the OrthoNext digital platform, a software tool for deformity analysis and preoperative planning in pediatric orthopedic procedures.

“Together, OrthoNext and the JuniOrtho Plating System provide a complete solution for surgeons looking for a plating system to address the specific demands of advanced deformity and trauma reconstruction of the lower extremities in the pediatric population,” said Orthofix President of Global Orthopedics Paul Gonsalves. “We are very pleased to receive the FDA clearance of the OrthoNext platform and excited to move forward with our full market launch of the JuniOrtho Plating System as we continue to deliver on our commitment to advancing pediatric orthopedics.”
 
Developed specifically for use with the JuniOrtho Plating System, the OrthoNext digital platform software enables the surgeon to accurately plan the osteotomy position to visualize the implant in relation to the anatomy. This unique platform is designed to streamline the selection of the precise size of device and enable optimal positioning for the patient’s body prior to the surgical procedure.
 
With this clearance, Orthofix has also initiated its U.S. and European full market launch of the JuniOrtho Plating System. Created specifically for pediatric patients, the JuniOrtho Plating System is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.
  
The JuniOrtho Plating System is offered in a wide range of plate sizes with a variety of lengths and accommodates both locking and non-locking screws corresponding to the plate size. The system is comprised of sterile implants and single-use tools to optimize efficiency during the procedure.
 
JuniOrtho brings products and resources together to give both medical professionals and families the best in pediatric orthopedic solutions.