FDA Clears Aurora Spine’s Sterile-Packed TiNano™ Coated Interbody Fusion Implants

Aurora Spine Corporation has gained U.S. FDA 510(k) clearance for its sterile-packed TiNano™  titanium plasma spray coated spinal fusion implants.

Background

Spinal implant developer Aurora Spine is carving a niche for itself with a series of innovative, minimally invasive, regenerative spinal implant technologies. One such technology, TiNano™, is the company’s unique Titanium Plasma Spray coating on PEEK Interbody implants, which allows for bone ingrowth due to its porous structure. Aurora says 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.

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.

Company comments

“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.

Source: Aurora Spine Corporation

 

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