Aurora Spine Gains FDA 510(k) Clearance for DEXA-C Cervical Interbody

By Julie A. Vetalice

Aurora Spine Gains FDA 510(k) Clearance for DEXA-C Cervical Interbody

Aurora Spine received FDA 510(k) clearance to market DEXA-C, a new line of cervical cages for anterior cervical discectomy with fusion. This clearance is the first using Aurora's patented DEXA technology, which creates a series of implants manufactured with varying densities to match a patient's bone density and DEXA T-Score. By comparing and using a product that matches a patient's bone density, the technology should promote quicker bone growth and employ superior fixation.

Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine, stated, "This approval is the first of its kind in the world by offering an implant based upon a patient's bone density. It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score, which indicates a patient's bone density. Today's implant options are all designed as a one-size-fits-all solution. Because implant materials do not match well with patients that have lower bone mass or a lower T-Score, it is preferred to implant a device that has the best chance of long-term fixation and promotes bone growth."

Source: Aurora Spine Corporation

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory