The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of interbodies, plates, and screws. The interbody device can be used as a stand alone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V). The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central hole and two holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
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