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Medtronic announces 510k clearance of pedicle screw system for adolescent idiopathic scoliosis
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Medtronic announced today it received clearance to treat 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, according to a company press release.
AIS is the most common type of scoliosis seen in children, affecting nearly one million children in the United States alone, Medtronic noted.
“This is a major milestone for surgeons and their pediatric patients,” Doug King, general manager of Medtronic’s Spine business, stated in the release. “With this clearance we will now be able to provide training and education to surgeons to treat children diagnosed with AIS.”
Pedicle screws are designed specifically for use in the thoracolumbar spine. They are frequently used in instrumentation procedures to affix rods to the spine to correct deformities.
“The opportunity to further research and study this patient population will allow us to move forward with our commitment and investment in pediatric innovation,” King continued. “Unlike adults, adolescent spines are still in a period of growth. Medtronic is committed to collaborating with the some of the world’s best surgeons to develop and advance technologies to address the unique needs of children.”