The American company Orthofix Medical Inc. obtained the U.S. Food and Drug Administration (FDA) 510(k) clearance for its OrthoNext™ digital platform that enables deformity analysis and preoperative planning for paediatric orthopaedic procedures with the JuniOrtho Plating Systems.
Developed specifically for use with the JuniOrtho Plating System™, the OrthoNext digital 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 paediatric patients, the JuniOrtho Plating System is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.
More information is available here.