Aurora Spine has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its interspinous fixation implant for spinal fusion, ZIP 51.
Developed as an alternative for pedicle screw fixation, the ZIP 51 offers stabilization and shares load during the TI-S1 thoracolumbar fusion procedures.
Aurora Spine president and CEO Trent Northcutt said: "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.
"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."
According to Aurora, ZIP 51 can also be used as an adjunct for interbody fusion, specifically for the treatment of degenerative disc disease, spondylolisthesis, trauma, and/or tumor.
The ZIP 51 implant features a large barrel that can be used for ZIP Graft or other bone material, as well as ZIP ONE-STEP locking mechanism, which eliminates the use of a set screw.