Spine
FDA clears spinal systems for idiopathic scoliosis
he FDA has issued 510(k) clearance for DePuy Synthes Spine’s Expedium, Viper and Viper 2 spine systems for patients with idiopathic scoliosis. According to a company press release, this is an expansion of the scoliosis indication for the pedicle screw systems, which now are indicated for both adolescents and adults.
“This FDA clearance is an important milestone for us as a company, and is also important for adolescent patients who will have greater access to the latest technology available if they require spine surgery for their scoliosis,” Namal Nawana, worldwide president of DePuy Synthesis Spine, stated in the release. “DePuy Synthes Spine remains committed to developing innovative technologies for adolescents with scoliosis.”