OrthoPediatrics’ eLLi Growing Rod System Earns Breakthrough Device Designation

The U.S. Food and Drug Administration (FDA) has granted OrthoPediatrics Corp. Breakthrough Device Designation for its new eLLi surgical device, an implant designed to address severe pathology associated with Early Onset Scoliosis (EOS).

eLLi offers clinicians a non-invasive means of extending the growing rods for pediatric patients. The rods provide increased force, enhanced mechanical reliability, and superior distraction precision, while also addressing safety concerns associated with current technology. eLLi gives surgeons a new alternative to address deformity of children’s growing spines with an advanced technology that will complement the company’s efforts to build a platform of EOS technologies.  

EOS can be associated with thoracic insufficiency, a potentially life-threatening condition. “Receiving the Breakthrough Device designation from the FDA is a great achievement for our team,” OrthoPediatrics President/CEO David Bailey said. “This product will be a great addition to our suite of products for pediatric patients with scoliosis and represents our commitment to continuous innovation and advancing healthcare for children all over the world. I’m proud of my colleagues for all the work they are doing to deliver novel technologies to our surgeon customers and the kids they treat!”   
 
The FDA’s Breakthrough Devices Program is targeted to medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Program is intended to give patients more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the agency’s mission to protect and promote public health.
 
Founded in 2006, OrthoPediatrics is focused exclusively on advancing pediatric orthopedics and has developed a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics currently markets 71 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and more than 70 countries worldwide.