CORUS™ Navigation System-GX

The CORUS™ Navigation System-GX consists of disposable surgical instruments (Navigation Access Chisel-G and Navigation Chisel Rasp-G) designed for use during spinal surgery to assist surgeons in locating and preparing facet joints in open or minimally invasive procedures. The instruments work with the Globus Medical ExcelsiusGPS™ navigation system to provide spatial positioning and orientation guidance for surgical instruments.

The subject device has nearly identical technological characteristics to its predicates, including the same indications for use, materials of manufacture, critical geometry, and principles of operation. The instruments are disposable, designed for compatibility with the ExcelsiusGPS navigation platform, and provide access to posterior spinal facet joints with decortication for bone preparation.

Not stated in this summary.

The CORUS™ Navigation System-GX is substantially equivalent because it shares identical technological characteristics with its predicates (same indications, materials, geometry, and operation), was evaluated through engineering analysis and geometric comparison demonstrating equivalent safety and efficacy for accuracy performance, and leveraged biocompatibility data from previously cleared instruments with equivalent materials and manufacturing. The device functions with the same predicate navigation platform software and hardware as the predicate instruments it replaces.