FDA clears new joint fusion system

X-spine received FDA clearance for the Silex sacroiliac joint fusion system.

The Silex system allows for fusion and stabilization of the sacroiliac (SI) joint in eligible patients when appropriate nonsurgical treatment has failed. Placed through a small incision, the device incorporates a proprietary dual-pitch compression-thread design and titanium plasma coating to stabilize the SI joint in fusion procedures, according to a press release. The implant’s design introduces bone graft into the joint and implant to achieve fusion. The implant and instrumentation suite also allows for direct exposure and preparation of the SI joint surface, placement of bone graft into the SI joint space under direct visualization and placement of bone graft directly within the Silex implant.

“Sacroiliac dysfunction is an important cause of pain and disability which has, until recently, been underdiagnosed and undertreated,” David Kirschman, MD, president and chief executive officer of X-spine, stated in a company release. “The Silex system achieves and efficient fixation of the SI joint while respecting the established principles of bone grafting and fusion to create long-term stability.”