Orthofix’s plating system wins FDA clearance and CE Mark

Orthofix Medical has received the US Food and Drug Administration (FDA) 510(k) clearance and European CE Mark approval for its JuniOrtho Plating System designed for paediatric patients.

The fixation system addresses the demands of advanced deformity and trauma reconstruction of the lower extremities in children.

It is offered in a range of plate sizes with a variety of lengths and accommodates both locking and non-locking screws, corresponding to the plate size.

The system uses sterile implants and single-use tools to reduce the risk of contamination and optimise efficiency during the procedure.

Additionally, JuniOrtho Plating System is complemented by a pre-operative planning software option that streamlines the implant selection prior to the surgical procedure.

This enables the surgeon to accurately plan the osteotomy position to visualise the implant in relation to the anatomy. It also helps them to select the precise size of the device to ensure the best fit and optimal positioning for the patient’s body.

Currently, the system is available in Europe and is expected to be launched in the US later this year.

Orthofix president and CEO Jon Serbousek said: “The JuniOrtho Plating System represents our continued commitment to advancing paediatric orthopaedics by providing surgeons with the devices they need to treat even the smallest of patients.

“We are excited to now be able to offer surgeons both internal and external fixation systems to expand our portfolio of paediatric deformity care solutions.”

The JuniOrtho Plating System is part of Orthofix Medical’s JuniOrtho line of pediatric solutions, which includes TL-HEX system, TrueLok Ring Fixation System and eight-Plate-Guided Growth System+.