Aurora Spine Corp., Carlsbad, Calif., announces that it has received U.S. Food and Drug Administration 510(k) clearance for sterile-packed titanium plasma spray coated (TiNano) spinal fusion implants. TiNano is Aurora Spine’s unique titanium plasma spray coating on PEEK Interbody implants. The coating allows for bone ingrowth due to its porous structure. TiNano-coated implants provide bone-titanium osseo-integration from the titanium coating, and the modulus and post-op imaging advantages of PEEK fusion implants.
“This FDA clearance is a major achievement for Aurora Spine. These intervertebral implants are developed to support the entire spine from cervical to lumbar, and to accommodate the company’s ZIP Minimally Invasive Interspinous Fusion System portfolio as well as other fusion products on the market,” said Trent J. Northcutt, President and Chief Executive Officer of the company.
“Patient safety is the most important goal for Aurora Spine, and that is the reason for every TiNano coated interbody implant being sterile packed,” said Laszlo Garamszegi, Chief Technology Officer of the company.
The FDA clearance includes several interbody fusion devices, including configurations for Anterior Cervical (ACIF), Anterior Lumbar (ALIF), Posterior Lumbar (PLIF), Transforaminal Lumbar (TLIF) and Direct Lateral (DLIF) interbody spacers.
