CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant

The CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant are posterior spinal instrumentation devices with integrated screw fixation designed to stabilize spinal segments. CAVUX FFS is used for temporary stabilization during posterior cervical fusion in revision cases for anterior pseudarthrosis (C3-C7). CORUS-LX is used for temporary stabilization during 1-2 level lumbar interbody fusion in patients with degenerative disc disease (L4-S1) who have failed conservative care.

Both devices feature medical-grade titanium alloy (6Al4V) construction with integrated screws that anchor into facet joints bilaterally through a posterior approach. The implants incorporate fenestrated windows to house bone graft and permit visualization of graft material and new bone formation. Multiple sizes accommodate varied patient anatomy, and delivery instruments include a physical stop to prevent over-insertion.

Not stated in this summary.

The substantial equivalence is based on identical intended use, technological characteristics, materials of construction, principles of operation, and design features between the subject devices and predicates (PCSS K241035, PMT FFS K220951, and PMT FFS-LX K230840). The submission modifies only the indications for use language to align with the more recent K241035 predicate clearance terminology, without changing any physical or functional properties. Since the devices perform the same function via the same mechanism, subject devices are as safe and effective as predicates.