Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021
HomeOrthofix Medical Inc.OrthoNext Digital Platform for the JuniOrtho Plating System Receives FDA Clearance

OrthoNext Digital Platform for the JuniOrtho Plating System Receives FDA Clearance

OrthoNext digital platform, is the only software tool in the market for deformity analysis and preoperative planning for pediatric orthopedic procedures. Orthofix Medical today announced the expansion of its pediatric offerings with the U.S. Food and Drug Administration (FDA) 510(k) clearance.

Developed specifically for use with the JuniOrtho Plating System, the OrthoNext digital platform software enables the surgeon to accurately plan the osteotomy position to visualize the implant in relation to the anatomy. This unique platform 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 pediatric patients, the JuniOrtho Plating System is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.

“Together, OrthoNext and the JuniOrtho Plating System provide a complete solution for surgeons looking for a plating system to address the specific demands of advanced deformity and trauma reconstruction of the lower extremities in the pediatric population,” said Orthofix President of Global Orthopedics Paul Gonsalves. “We are very pleased to receive the FDA clearance of the OrthoNext platform and excited to move forward with our full market launch of the JuniOrtho Plating System as we continue to deliver on our commitment to advancing pediatric orthopedics.”

The JuniOrtho Plating System is offered in a wide range of plate sizes with a variety of lengths and accommodates both locking and non-locking screws corresponding to the plate size. The system is comprised of sterile implants and single-use tools to optimize efficiency during the procedure.

The OrthoNext platform and the JuniOrtho Plating System will be on display at the Pediatric Orthopaedic Society of North America (POSNA) annual meeting in Dallas, Texas May 12-15. For those attending POSNA, please visit booth 13 to learn more about Orthofix’s JuniOrtho line of pediatric solutions that includes the TL-HEX TrueLok Hexapod System, TrueLokRing Fixation System, eight-Plate Guided Growth System+, and many others. JuniOrtho brings products and resources together to give both medical professionals and families the best in pediatric orthopedic solutions. To learn more, please visit

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

Matthew Cranfill New ExtriCARE USA Director Of Clinical Services

"Matt's impressive experience and skillset easily made him our top pick," said Peter Mason, President of ExtriCARE USA.

FDA Authorizes Software that Can Help Identify Prostate Cancer

The software is called Paige Prostate and is compatible for use with slide images that have been digitized using a scanner.

Shannon Lantzy MedCrypt New VP of Consulting

"I met Shannon at a healthcare-related event several years ago and was immediately impressed with her passion and drive to move healthcare into a digital future," said Mike Kijewski, CEO of MedCrypt.

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy