Orthofix (NSDQ:OFIX) today said it received FDA clearance and CE Mark approval for its JuniOrtho plating system.
The device is designed specifically for pediatric patients and is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.
“The field of deformity correction is rapidly evolving with multiple technical and technological advances every year,” said Philip McClure, an orthopedic surgeon at the International Center for Limb Lengthening in Baltimore. “External fixators are an incredibly powerful tool in caring for deformities in children around the world. Improved designs of internal fixation devices have allowed us to provide complimentary options to external fixators to benefit our patients and their families. Our goal is to obtain the best possible outcome so children can enjoy their lives after deformity correction surgery.”
The system can be used with a pre-operative planning software option that allows surgeons to streamline implant selection. It also is designed to enable surgeons to accurately plan osteotomy position to visualize the implant in relation to the anatomy. The system helps surgeons select the precise size of devices for best fit and optimal positioning for individual patient bodies. The software is currently available in Europe and is planned to launch in the U.S. later this year.
“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,” president and CEO Jon Serbousek said in a news release. “We are excited to now be able to offer surgeons both internal and external fixation systems to expand our portfolio of pediatric deformity care solutions.”
The system comes in a variety of plate sizes with varying lengths to accommodate locking and non-locking screws corresponding to the plate size. It is comprised of sterile implants and single-use tools to reduce contamination during the procedure.
