FDA OKs CoreLink’s Foundation 3D Anterior Lumbar (ALIF)

CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market The Foundation 3D Anterior Lumbar (ALIF) Interbody device. This marks the launch of the latest addition to CoreLink’s Foundation 3D Interbody Cage family.
 
Jay Bartling, CEO, said, “The Foundation 3D ALIF demonstrates our increasing capabilities with 3D printing titanium alloy. We’re proud to have the largest ALIF cage footprint on the market, which will allow surgeons to maximize endplate contact area and hold up to 8cc’s of graft.”
 
Prior to the newly 510(k) cleared ALIF device, CoreLink released 3 other sterile-packaged Foundation 3D interbody cages: Cervical, Straight Lumbar, and Curved Lumbar.
 
“I have been very pleased since converting to Foundation 3D Cervical last year. I am excited about the Mimetic Metal technology and have had great clinical outcomes with very happy patients.” said Todd Stewart, M.D.
 
Foundation 3D ALIF leverages CoreLink’s proprietary Mimetic Metal technology that mimics key characteristics of natural bone—100 percent open-pore architecture and micro roughened porosity with significant hydro-wicking properties. The new ALIF design also features patent pending StrutSure technology which creates a combination of load-sharing support structure and interconnected lattice designed to provide optimal balance between strength, stiffness, and stability. This unique structure minimizes implant material density, providing good imaging characteristics. Foundation 3D devices have a low modulus that may reduce stress shielding and enable the benefits of Wolff’s Law.
 
CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where the portfolio of Foundation 3D Products will be featured.