Medical device gets slimmer

Aurora Spine receives FDA 510(k) clearance for pre-packaged sterile ZIP 51 MIS interspinous fixation implant.


Carlsbad, California – Aurora Spine Corp. officials announce that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51, Aurora Spine's slimmest minimally invasive interspinous fixation implant for spinal fusion.

The ZIP 51 was developed as an alternative to pedicle screw fixation and designed for stabilization and load sharing during the TI-S1 thoracolumbar fusion procedures. ZIP 51 is also intended to be an adjunct to interbody fusion, specifically for the treatment of degenerative disc disease, spondylolisthesis, trauma, and/or tumor.

"Aurora is changing spine surgery, and we are thrilled to receive FDA clearance with the ZIP 51, another key product in the Aurora Spine MIS Fusion System," said Trent J. Northcutt, president and CEO of Aurora Spine. "The new ZIP 51 represents our 5th FDA clearance in 11 months and maintains our position at the forefront, introducing advanced, innovative, minimally disruptive spine surgery technologies. This addition to our product portfolio serves spine surgeons performing our screw-less minimally invasive procedure that prefer a slimmer profile and flared lower spikes. The success of our screw-less spine procedure is a testament to our laser focus on disruptive technology and our commitment to - Simplifying the Complex."

The proprietary ZIP ONE-STEP locking mechanism eliminates the use of a set screw. Each ZIP 51 implant features a large barrel designed for ZIP Graft or other bone material. The ZIP 51 is designed in various sizes to accommodate variations in patient anatomy.

Source: Aurora Spine