FDA Clears X-spine Joint Fusion System
Late March saw X-spine Systems Inc. receive 510(k) clearance from the U.S. Food and Drug Administration for its Silex sacroiliac (SI) joint fusion system. The system is designed for the fusion and stabilization of the SI joint in eligible patients for whom appropriate non-surgical treatment has failed. The device can reportedly be placed through a small incision, and incorporates a proprietary dual-pitch compression-thread design and titanium plasma coating to stabilize the SI joint in fusion procedures.
According to X-spine, Silex is a true bony fusion and arthrodesis system. The implant and instrumentation suite 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 itself, the company claims.
“Sacroiliac dysfunction is an important cause of pain and disability which has, until recently, been underdiagnosed and undertreated,” said David Kirschman, M.D., a former spine surgeon and president and CEO of X-spine. “The Silex system achieves an efficient fixation of the SI joint while respecting the established principles of bone grafting and fusion to create long-term stability.”
The system was developed with intensive surgeon input with the goal of maximizing the efficiency and performance of the sacroiliac fusion procedure.
X-spine is a spinal device company based in Miamisburg, Ohio.