NuVasive Receives FDA Clearance for MAGEC with RELINE Small Stature

By Julie A. Vetalice

NuVasive received FDA 510(k) clearance for use of a redesigned MAGEC® growing rod system with the RELINE® Small Stature pediatric deformity fixation system.

MAGEC uses magnetic technology within adjustable growing rods to treat early-onset scoliosis. Updated components in the system are intended to improve surgeon use, while a new 5.0MM diameter rod is designed to provide optimal strength to growing-rod constructs when used with RELINE Small Stature. RELINE Small Stature is the only small stature system that is compatible with the new 5.0MM MAGEC rod.

NUVA's pediatric initiatives include establishment of a pediatric-specific salesforce and a pediatric spinal deformity-centric program, "Embracing the Journey Together," addressing research, education and event support.

The new product offerings are showcased at the Scoliosis Research Society 52nd Annual Meeting, underway now through September 9.

Sources: NuVasive, Inc.; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory