NuVasive announced on Sept. 6 that it won FDA 510(k) clearance for its spinal implant system to treat early onset scoliosis.
Specifically, the FDA approval is for the redesigned MAGEC system with its RELINE Small Stature system.
The MAGEC system uses magnetic technology with adjustable growing rods. According to the San Diego medical device and surgery company, the system makes surgical outcomes more reproducible and is easier for surgeons to use.
The system is designed to be paired with the company’s RELINE Small Stature platform, which looks to provide optimal strength to growing-rod constructs to help improve clinical outcomes.
"The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive.
Last October, NuVasive said it received expanded FDA clearance for its MAGEC system.
According to the company, it has made meaningful gains in both the adult and pediatric deformity markets, a $2.5 billion opportunity over the last two years.