Orthofix Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA), as well as European CE mark approval for its JuniOrtho plating system.

Designed specifically for paediatric patients, the new fixation system will help better meet the demands of advanced deformity and trauma reconstruction of the lower extremities.

The JuniOrtho plating system, which is available in a range of plate sizes with different lengths, accommodates both locking and non-locking screws corresponding to the plate size.

Orthofix’s system features sterile implants and single-use tools to minimise the risk of contamination and optimise efficiency during the procedure.

The JuniOrtho plating system is complemented by a pre-operative planning software option

The new plating system is said to be complemented by a pre-operative planning software option, which streamlines the implant selection before to the surgical procedure. Currently, the software is provided in Europe and planned for launch in the US by the end of this year.

Orthofix’s advanced platform helps the surgeon to precisely plan the osteotomy position to visualise the implant in relation to the anatomy.

The JuniOrtho plating system is part of the JuniOrtho line of paediatric solutions, which includes the TL-HEX system, TrueLok ring fixation system and eight-Plate Guided Growth System+.

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

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

In February 2019, Orthofix Medical secured FDA approval for its M6-C artificial cervical disc to treat patients with cervical disc degeneration.

Based in Lewisville of Texas, Orthofix mainly offers musculoskeletal products and therapies. The company’s spine and orthopaedic extremities products are available in over 70 countries.