Navigation Module of the Cortium® System

The Navigation Module of the Cortium® System is a set of non-sterile, reusable surgical instruments (drills, taps, screwdrivers) made from stainless steel. It is used with the Medtronic StealthStation surgical navigation system to assist surgeons in precisely locating anatomical structures and placing Cortium® Universal OCT Spinal Fixation System screws during spinal surgery. The instruments are not intended for navigation of occipital screws.

The subject and predicate devices have nearly identical technological characteristics including principles of operation, indications for use, materials, instrument style and sizes, compatible screw options, and instrument critical geometries and functional length. Minor differences between subject and predicate do not raise new safety or effectiveness issues.

ASTM F899 (stainless steel conformance). The device was tested for compatibility using StealthStation S8 software version 2.1.0. Critical geometry assessment and software registration verification were performed as non-clinical testing.

The Navigation Module is substantially equivalent because it has nearly identical technological characteristics to predicate devices (K143628, K170679, K230614, K200845), demonstrates equivalent positional accuracy in critical geometry and software registration testing, uses identical manufacturing materials and processes to previously cleared instruments, and employs the same validated cleaning and sterilization methods as cleared predecessors.