EZ-FIDUCIALS

EZ-Fiducials is a stereotactic instrument that provides fixed reference points for neurosurgical procedures requiring CT imaging. The device consists of four titanium screws, a manual screwdriver, and an electric battery-operated screwdriver (EZ-Driver), all provided as a single-use, gamma-sterilized kit for implantation into the skull.

The device uses titanium screws with a 2.0mm insertion size and 1.98mm threaded diameter, comparable to the predicate's 1.6mm size. The electric EZ-Driver operates at 30 rpm using single-use lithium batteries, slower than the reference device's 120 rpm but functionally equivalent for screw insertion. Both the electric and manual screwdrivers enable forward/reverse operation for screw placement and removal. All components are sterile, single-use, and disposable.

ASTM F543-23 standard was applied to validate screw deflection and bone purchase characteristics. Testing included biocompatibility, packaging, sterility, and performance validation using a Coordinate Measuring Machine (CMM) to verify firm screw purchase into bone simulant.

The proposed device combines the screw design and intended use of the predicate (Navigus Unibody Fiducial Marker System) with an accessory screwdriver functionally comparable to the reference device (OsteoMed Pinnacle Driver). Both predicates support the same stereotactic surgical application. Although the predicate was cleared without a screwdriver and the EZ-Driver operates at lower rpm, bench testing demonstrates the electric driver performs adequately for screw insertion, and the manual screwdriver provides an equivalent fallback. The kit format introduces no safety or effectiveness concerns compared to devices used individually for the identical indication.