FDA Clears New Spinal Implant

Megan Brooks

Disclosures

August 17, 2018

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Foundation 3D Anterior Lumbar (ALIF) spinal implant from CoreLink LLC, the company has announced.

"This marks the launch of the latest addition to CoreLink's Foundation 3D Interbody Cage family," the company notes in a news release

"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," CEO Jay Bartling said in the release.

CoreLink has previously released three other sterile-packaged Foundation 3D interbody cages: cervical, straight lumbar, and curved lumbar.

Foundation 3D ALIF uses CoreLink's proprietary mimetic metal technology, which mimics key characteristics of natural bone, with 100% open-pore architecture and micro roughened porosity with significant hydro-wicking properties, the company explains.

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," the company said.

CoreLink will exhibit the new device in September at the North American Spine Society's annual meeting in Los Angeles, California.

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