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FDA clears NuVasive MAGEC system used with pediatric deformity fixation system
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NuVasive Inc. announced it has received FDA 510(k) clearance for the use of its redesigned MAGEC scoliosis treatment system with its RELINE Small Stature system, which is a comprehensive pediatric deformity fixation system.
Redesigned components in the MAGEC system make it easier for the surgeon to use and help make surgical outcomes more reproducible, according to a company press release.
The release noted the MAGEC system, for which a new 5.0-mm diameter rod was just introduced, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes when paired with the NuVasive low-profile RELINE Small Stature system.
“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 5.0-mm rod,” Matt Link, executive vice president of strategy, technology and corporate development at NuVasive, said in the release. “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.”
The company will feature these products later this week at the Scoliosis Research Society Annual Meeting in Philadelphia.
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