X-Spine Systems Cleared in U.S. for Facet Fusion Device
X-Spine Systems Inc. has gained 510(k) clearance from the U.S. Food and Drug Administration for its Zygafix facet fusion system. The system is designed to provide fusion and stabilization of the facet joint (also called the zygapophyseal joint) in eligible patients whom appropriate non-surgical treatment has failed. The device is made to 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.
X-Spine designed Zygafix with a titanium compression screw, which in the company’s estimation compares favorably to intra-facet systems that consist of a solid bone implant place into the facet joint, not providing mechanical fixation. The titanium implant is packed with bone graft, reportedly creating a fusion mass across the facet joint and imparting long-term stability. The implant and instrumentation suite is meant to allow either for open or minimally invasive exposure. The implant can be placed through a simple trans-facet approach in addition to typical facet approaches, according to X-Spine.
“Facet systems are continuing to gain in popularity as a less-invasive alternative to pedicle screws for posterior spinal stabilization,” said 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 system joins X-Spine’s previously cleared Fixcet traditional solid facet screw system top create a suite of options for facet surgeries. Together with Axle and Silex, Zygafix completes a trio of devices from the company that address spine fusion sites from and interspinous, sacroiliac, and transfacet approach.
X-Spine Systems is based in Miamisburg, Ohio, and focuses on spine disease products.