CYLOX ST interbody system - Spinal cage

Intended purpose

The CYLOX ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach. When used as a standalone system, CYLOX ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw. When used with supplemental fixation, such as anterior cervical plates, CYLOX ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).