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Indications for Use: CORUS™ Spinal System–LX

The CORUS™ Spinal System-LX is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

Device Description: The CORUS™ Spinal System-LX disposable instruments are used to access and prepare the posterior cervical or lumbar spine for joint fusion by decortication of bone surfaces, including the posterior aspects of the facet joints, combined with application of allograft or autograft in patients with or without anterior or posterior instrumentation. It is recommended that commercially available autograft or allograft be used to aid fusion. Autograft or allograft material is not supplied as part of the system.

Indications for Use: CORUS™ Navigation Access System-LX

The CORUS™ Navigation Access System-LX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation Access System-LX is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description: The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation.

Indications for Use: CAVUX® FFS-LX

CAVUX FFS-LX, Facet Fixation System, Lumbar (CAVUX FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY® Bone Screw. CAVUX FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.

CAVUX FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s).

CAVUX FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

Device Description: CAVUX Cages are used in conjunction with ALLY Bone Screws as an integrated construct referred to as the CAVUX Facet Fixation System “CAVUX FFS-LX”. The device achieves facet fixation by spanning the interspace with points of fixation at each end of the construct. The device provides rigid fixation as an adjunct to fusion with the bone screw providing additional anchoring into the lateral mass. The titanium constructs are offered in various footprints and heights and are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). CAVUX FFS-LX is single-use only, provided sterile (gamma sterilized) with pre-attached, disposable, delivery handl