Orthofix Medical’s Pediatric Orthopedic Procedure Planner Gets 510(k) Clearance

Orthofix Medical has obtained FDA 510(k) clearance for its OrthoNext digital platform, a software tool that assists in deformity analyses and preoperative planning for pediatric orthopedic procedures.

The software was developed specifically for use with the company’s JuniOrtho Plating System, a complete plating system for advanced deformity and trauma reconstruction of the lower extremities in pediatric patients, including the treatment of congenital deformities in the proximal femur, distal femur and tibia, as well as articular fractures.

The system allows surgeons to accurately visualize the implant in relation to the patient’s anatomy, assisting in selecting the correct size of device and positioning prior to surgery.