Orthofix receives FDA clearance, CE Mark approval for JuniOrtho plating system
Orthofix Medical Inc. has received FDA 510(k) clearance and European CE Mark approval for the JuniOrtho plating system, according to a company press release.
The system, composed of sterile implants and single-use tools, is designed for correction of advanced deformities and trauma reconstruction of the lower extremities, according to the release.
“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,” Jon Serbousek, president and CEO of Orthofix, said in the release. “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,” he added.