Aurora Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for sterile-packed titanium plasma spray coated (TiNano) spinal 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,” says Trent J Northcutt, president and chief executive officer of Aurora Spine.
According to a press release, TiNano is Aurora Spine’s unique titanium plasma spray coating on polyether ether ketone (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,” says Laszlo Garamszegi, chief technology officer of the company.
The FDA clearance includes several interbody fusion devices, including configurations for anterior cervical, anterior lumbar, posterior lumbar, transforaminal lumbar and direct lateral interbody spacers.