Innovasis Navigation Instruments

The Innovasis Navigation Instruments are reusable surgical instruments made of medical-grade stainless steel used to prepare and insert pedicle screws during spinal surgery. They work with the Medtronic StealthStation navigation systems to help surgeons precisely locate anatomical structures in open or minimally invasive procedures, specifically for the Vector M-S and Excella screw systems.

The subject and predicate devices share identical principles of operation, indications for use, manufacturing materials, and biocompatibility. They have the same instrument types and sizes, critical geometry (functional length and Nav Lock connection feature geometry), and sterility requirements. The only difference is that this submission adds Vector M-S Navigation Instruments to the existing Excella Navigation Instruments already cleared.

Not stated in this summary.

The devices are substantially equivalent because they have nearly identical technological characteristics with only minor differences that raise no new safety or effectiveness issues. Engineering analysis and geometric comparison to predicate devices, combined with validation testing demonstrating navigation compatibility with Medtronic StealthStation Systems S7 and S8, confirmed mechanical performance equivalence. The subject device operates on the same principles, has the same indications for use, identical manufacturing and biocompatibility, and meets the same critical geometry and sterility standards as the cleared predicates.