FDA Clears Aurora Spine’s Sterile Zip 51 MIS Interspinous Fixation Implant

Aurora Spine Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51, a slim 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 also is intended to be an adjunct to interbody fusion, specifically for the treatment of degenerative disc disease, spondylolisthesis, trauma, and/or tumor.

“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/CEO of Aurora Spine. “The new ZIP 51 represents our fifth FDA clearance in 11 months. 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 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.

Based inCarlsbad, Calif., Aurora Spine is an early stage company that develops minimally invasive, regenerative spinal implant technologies.