Three New FDA-Approved Spinal Implant Systems

Officials from X-spine, a global leader in the design and manufacture of medical devices for the treatment of spinal disease, announce the market launch of three recently U.S. FDA-cleared spinal implant systems. The systems are the IRIX-C cervical integrated interbody fusion system, the AXLE-X extended angle interspinous fixation system, and the SILEX sacroiliac joint fusion system.

IRIX-C represents the latest generation of X-spine cervical fixation technology. With benefits to both patient and surgeon, the implanted device lies completely within the disk space, with zero-impingement on adjacent structures. Incorporating state of the art biomaterials and manufacturing processes, the device combines a polymer body, titanium plasma coating of bone-apposing surfaces, and integrated variable-angle screw fixation. Additionally, IRIX-C represents the first in a forthcoming family of IRIX integrated interbody devices currently being developed by X-spine.

AXLE-X represents the newest evolution of X-spine’s established line of AXLE interspinous fixation and fusion devices. Utilizing a bevel-angle plate design and novel unidirectional tooth pattern, AXLE-X demonstrates superior pull-off resistance to alternative designs in laboratory studies simulating fixation at the laminar-spinous junction.

SILEX is X-spine’s novel sacroiliac fusion device. By utilizing a combination of unidirectional compression threading, titanium coating, and internal fusion chamber, SILEX provides excellent biomechanics for sacroiliac fusion procedures.

IRIX-C, AXLE-X and SILEX join X-spine’s continually expanding portfolio of innovative spinal devices, including the ZYGAFIX facet fusion system, AXLE interspinous fusion system, CERTEX cervicothoracic fixation system, the CALIX PC titanium-coated intervertebral fusion system, the FIXCET facet fixation system, the FORTEX and X90 pedicle screw systems, the CALIX cervical interbody and lumbar VBR systems, the SPIDER cervical plating system, and the HGRAFT spinal allograft system.

Source: X-spine