CoreLink has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Foundation 3D anterior lumbar (ALIF) interbody device.
CoreLink already launched three other sterile-packaged Foundation 3D interbody cages, including cervical, straight lumbar, and curved lumbar, prior to the newly approved ALIF device.
The Foundation 3D ALIF device features CoreLink’s Mimetic Metal technology, which helps to integrate crucial characteristics of natural bone with open-pore architecture and micro roughened porosity with significant hydro-wicking properties.
CoreLink CEO Jay Bartling 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.”
The firm’s new ALIF device also features patent pending StrutSure technology that enables to create a combination of load-sharing support structure and interconnected lattice to offer optimal balance between strength, stiffness, and stability.
The device’s unique structure is also said to minimize implant material density, enabling to deliver better imaging characteristics.
Foundation 3D devices will have a low modulus, which will help decrease stress shielding and enable the benefits of Wolff’s Law.
The company will showcase its Foundation 3D products portfolio at the North American Spine Society’s annual meeting in Los Angeles, which will take place from 26 to 28 September.
Dr Todd Stewart said: “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.”
CoreLink, which is known as The Source for Spine, is a vertically integrated manufacturer of spinal implant systems.
An implant is a medical device produced to replace a missing biological structure support a damaged biological structure or enhance an existing biological structure.
Based in St. Louis of Missouri, the company designs, manufactures and supplies a range of spinal implants and instrumentation.
The company’s product portfolio is comprised of pedicle screw systems, interbody spacers, plates, biologics and surgical instruments.