FDA Clearance of New Implant System

X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Silex sacroiliac (SI) joint fusion system.

The newly cleared Silex system allows for fusion and stabilization of the SI joint in eligible patients whom appropriate non-surgical treatment has failed. The device can be placed through a small incision, incorporating a proprietary dual-pitch compression-thread design together with titanium plasma coating, to stabilize the SI joint in fusion procedures. The design of the implant allows for the introduction of bone graft into the joint and implant in order to achieve a solid fusion.

Unlike some recently introduced SI arthroplasty-type systems, which are not compatible with direct bone grafting of the SI joint space, the 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.

“Sacroiliac dysfunction is an important cause of pain and disability which has, until recently, been underdiagnosed and undertreated,” states 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.

The Silex SI joint fusion system joins X-spine’s continually expanding portfolio of innovative spinal devices, including the AXLE Interspinous Fusion System, Certex Cervico-thoracic Fixation System, the CALIX PC Titanium-coated Intervertebral Fusion System, the FIXCET Facet Fixation System, the FORTEX and X90 Pedicle Screw Systems, the SPIDER Cervical Plating System, and the HGRAFT Spinal Allograft System.