Medtronic Inc. (NYSE:MDT) won 510(k) clearance from the FDA for a pedicle screw designed to treat adolescent idiopathic scoliosis.
The Twin Cities medical device colossus said the FDA’s Center for Devices & Radiological Health gave the nod to its TSRH Spiral system pedicle screw. It’s the second Medtronic AIS treatment to land FDA clearance.
AIS is the most common pediatric spine condition, affecting nearly one million U.S. adolescents, according to the company.
“This additional AIS clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with AIS,” Doug King, president of Medtronic Spinal said in a prepared statement. “This clearance also provides an opportunity to further research and study these patients allowing us to move forward with our commitment and investment in pediatric innovation.”
This FDA approval comes less than a month after a second class I recall on Medtronic’s SynchroMed II drug infusion pumps.