FDA 510(k) clearance for TiNano-coated implants

Aurora Spine's unique titanium plasma spray coating on PEEK Interbody implants allows for bone ingrowth due to its porous structure.

February 18, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations Materials People/Facilities

Carlsbad, California - Aurora Spine Corp. received U.S. Food and Drug Administration (FDA) 510(k) clearance for sterile-packed titanium plasma spray coated (TiNano) spinal fusion medical 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 CEO of the company.

TiNano is Aurora Spine's unique Titanium Plasma Spray coating on PEEK Interbody implants allowing for bone ingrowth due to its porous structure. TiNano-coated implants provide the advantages of all implant materials, bone-titanium osseo-integration from the titanium coating, as well as the modulus and post-op imaging advantages of PEEK fusion implants.

"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, CTO 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.

Source: Aurora Spine