FDA Clearance of Zygafix Facet Fusion System

Officials from X-spine, a global leader in the design and manufacture of medical devices for the treatment of spinal disease, announce a new FDA clearance for the Zygafix Facet Fusion System. The newly-cleared Zygafix system allows for fusion and stabilization of the facet joint (also termed the zygapophyseal joint) in eligible patients whom appropriate non-surgical treatment has failed. The device can be placed through a minimally-invasive approach, and incorporates a hollow fenestrated titanium compression screw with internal bone graft in order to achieve a solid fusion.

Unlike intra-facet systems, which simply consist of a solid bone implant wedged into the facet joint which do not provide mechanical fixation, the Zygafix is a true fixation system incorporating a titanium compression screw. The implant is packed with bone graft and creates a fusion mass across the facet joint and imparts long-term stability. The implant and instrumentation suite allows for either open or minimally-invasive exposure. Additionally, the implant can be placed through a simple trans-facet approach in addition to typical facet approaches.

“Facet systems are continuing to gain in popularity as a less-invasive alternative to pedicle screws for posterior spinal stabilization,” states David Kirschman M.D., a former spine surgeon and president and CEO of X-spine. “The Zygafix system is unique in that it allows for both direct bone grafting and mechanical screw fixation of the facet joint within a single implant through a minimally invasive approach.”

The Zygafix joins the previously cleared X-spine Fixcet traditional solid facet screw system to give surgeons a choice in facet systems to appropriately address individual pathologies. The Zygafix system, in addition to the previously-cleared AXLE and SILEX systems, completes X-spine’s product triad of novel devices to treat the emerging spinal fusion sites available to today’s spine surgeon: interspinous, sacroiliac, and transfacet.