FDA clears CoreLink’s new spinal implant

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Spinal implant maker CoreLink has landed FDA 510(k) clearance for a new anterior lumbar (ALIF) interbody device.

The Foundation 3D ALIF uses the company’s proprietary mimetic metal technology, which mimics natural bone characteristics, including 100% open-pore architecture and micro-roughened porosity with hydro-wicking properties.

The new ALIF design also has patent-pending technology that creates a combination of load-sharing support structure and interconnected lattice designed to provide an optimal balance between strength, stiffness and stability, according to the company. The structure was designed to minimize implant material density and provide good imaging characteristics. Foundation 3D devices have a low modulus that may reduce stress shielding and enable the benefits of Wolff’s Law, which states that bone in a healthy person will adapt to the loads under which it is placed.

“The Foundation 3D ALIF demonstrates our increasing capabilities with 3D printing titanium alloy,” said Jay Bartling, CEO of St. Louis-based CoreLink, in a prepared statement. “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 three other sterile-packaged Foundation 3D interbody cages: cervical, straight lumbar, and curved lumbar.

In June, CoreLink acquired the privately held Israeli medical device company Expanding Orthopedics and its FDA-cleared expanding and articulating FLXfit and FLXfit 15 titanium transforaminal lumbar interbody fusion systems.

 

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