Medtronic has received 510(k) clearance from the FDA for its CD HORIZON system for treatment of adolescent idiopathic scoliosis (AIS).
This marks the first such clearance by the FDA under the Agency’s newly established category for pediatric AIS patients treated with posterior pedicle screw instrumentation.
David L. Skaggs, MD, Professor and Chief of Orthopaedic Surgery at the Children’s Hospital in Los Angeles says getting children back to their active lives and potentially reducing the need for additional surgeries are two key advantages of using pedicle screws.
“Using pedicle screws in the treatment of Adolescent Idiopathic Scoliosis gives my patients the best chance of correcting their spine and chest deformity, and preventing future surgeries,” said Dr. Skaggs.
Press release: Medtronic Announces CD HORIZON® System 510k Pedicle Screw Clearance for Adolescent Idiopathic Scoliosis …