CoreLink Surgical wins FDA clearance for stand-alone anterior lumbar system

CoreLink Surgical announced that it has received FDA 510(k) clearance for its M3 Stand-Alone Anterior Lumbar (ALIF) System.

“M3 is our first stand-alone inter body fusion device to feature 3D printing. I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products,” Jay Bartling, CEO of CoreLink, said in a press release.

The M3 system is a 3-screw, integrated fixation device used in ALIF procedures. It features a universal bi-directional design with an intuitive locking mechanism. The M3 system was developed using CoreLink’s Mimetic Metal technology with a unique patent pending StrutSure technology that creates a combination of load-sharing support structure and interconnected lattice to minimize material density for imaging.

The new clearance allows for additional sizing options to fit to fit unique anatomical sizes.

“I’m always in pursuit of sizing cages to capture as much of the cortical ring that borders the endplates as possible. A larger cage option allows me a more appropriate fit for some patients,” said neurosurgeon Dr. Justin Owen. “Additionally, a larger cage can be helpful for greater surface contact with the endplates, which can enhance stability for a higher likelihood for fusion.”