August 16, 2018 10:47 AM Eastern Daylight Time
ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market The F3D Anterior Lumbar (ALIF) Interbody device. This marks the launch of the latest addition to CoreLink’s F3D Interbody Cage family.
Jay Bartling, CEO, said, “The F3D 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.”
“I have been very pleased since converting to F3D Cervical last year. I am excited about the Mimetic Metal technology and have had great clinical outcomes with very happy patients.”
Prior to the newly 510(k) cleared ALIF device, CoreLink released 3 other sterile-packaged F3D interbody cages: Cervical, Straight Lumbar, and Curved Lumbar.
“I have been very pleased since converting to F3D Cervical last year. I am excited about the Mimetic Metal technology and have had great clinical outcomes with very happy patients.” said Todd Stewart, MD.
F3D ALIF leverages CoreLink’s proprietary Mimetic Metal™ technology that mimics key characteristics of natural bone – 100% 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. F3D 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 F3D Products will be featured.
About CoreLink
CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.
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