X-spine launches three USFDA-cleared spinal implant systems

Oct 9 2013

X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces the market launch of three recently USFDA-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.

X-spine will be exhibiting the new IRIX-C™, AXLE-X™ and SILEX™ systems, along with its complete line of spinal devices, at the North American Spine Society Meeting in New Orleans, October 9th through 11th.

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.