FDA approves X-spine’s Zygafix facet fusion system


X-spine has received FDA clearance its Zygafix system, which is indicated for fusion and stabilisation of the facet joint in eligible patients in whom appropriate, non-surgical treatment has failed.

According to a company press release, 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.

The press release reported that the Zygafix is a true fixation system that incorporates a titanium compression screw. It added that 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 stabilisation,” states David Kirschman, a former spinal surgeon and president and chief executive officer 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.”