Market Overview

CoreLink, LLC Announces 510(k) Clearance for Foundation™ 3D Anterior Lumbar (ALIF)


, 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 FoundationTM 3D Anterior
Lumbar (ALIF) Interbody device. This marks the launch of the latest
addition to CoreLink's Foundation 3D Interbody Cage family.

This press release features multimedia. View the full release here:

Foundation 3D (Photo: Business Wire)

Foundation 3D (Photo: Business Wire)

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

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, MD.

Foundation 3D 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. 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.

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

Be a part of something at The Source.

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