Medical devices maker NuVasive has secured 510(k) clearance from the US Food and Drug Administration (FDA for its redesigned Magec system to be used with Reline small stature system.
Magec system uses an advanced magnetic technology within adjustable growing rods for the treatment of early-onset scoliosis in a less invasive manner.
The system now features latest advancements, comprising of redesigned components that will provide better assistance for the surgeon, as well as make surgical outcomes more reproducible.
Magec system also includes new 5.0 millimeter rod, which can be paired with the low-profile Reline small stature system that offers optimal strength to growing-rod constructs to help improve clinical outcomes.
Reline small stature is a comprehensive pediatric deformity fixation system that will help to achieve optimal construct strength with a reduced implant profile.
It is the only small stature system, which is compatible with the new 5.0 millimeter Magec rod.
The company will showcase the new system at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course in Philadelphia, which will be held from 6 to 9 September.
NuVasive strategy, technology and corporate development executive vice president Matt Link said: "As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod.
"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."
NuVasive manufactures access instruments, implantable hardware, biologics and software systems for surgical planning and navigation, as well as and imaging solutions, magnetically adjustable implant systems for spine and orthopedics and intraoperative monitoring service offerings.
Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.