Evolution Spine Navigation Instruments

The Evolution Spine Navigation Instruments are reusable surgical instruments designed to assist surgeons in precisely locating anatomical structures during spinal surgery. They are used with the Medtronic StealthStation S8 Navigation System to prepare and place pedicle screws in either open or minimally invasive procedures, and work with specific screw systems including Whistler Modular Pedicle and Stowe Pedicle systems.

The instruments are made of stainless steel per ASTM F899 and include awls, probes, taps, and drivers. They have substantially equivalent technological characteristics to predicate devices in design, intended use, material composition, function, and range of sizes. The devices are compatible only with the Medtronic StealthStation S8 Navigation System hardware and software.

ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Worst-case instrument constructs were tested per this standard to verify performance criteria for pedicle screw insertion under computer-assisted guidance.

Evolution Spine Navigation Instruments are substantially equivalent because they demonstrate the same design, intended use, material composition (stainless steel ASTM F899), function, and range of sizes as predicate devices. The worst-case constructs met and exceeded performance criteria for pedicle screw insertion per ASTM F2554-18 testing, demonstrating equivalent accuracy performance. Biocompatibility was addressed through identical manufacturing materials and processes to previously cleared devices. The indications for use are nearly identical to predicates with only minor changes that do not impact intended use.