Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

The Innovasis Navigation Instruments are non-sterile, reusable surgical instruments (taps and drivers made of stainless steel) designed to work with the Globus ExcelsiusGPS robotic navigation system to assist surgeons in precisely placing pedicle screws during non-cervical spine surgery in skeletally mature patients, whether in open or minimally invasive procedures.

The subject instruments have equivalent design, dimensions, materials (stainless steel), sterility status (non-sterile, end-user sterilized), and principles of operation to predicate devices. Both taps and drivers provide navigation array attachment for spherical marker tracking and perform identical functions: taps tap the pedicle for screw placement, while drivers drive screws into the pedicle in open, reduction, and minimally invasive configurations.

ASTM F899 (stainless steel specification) is cited for materials. The document references verification testing for registration with the navigation system and fit within the guide tube of the end-effector, but does not cite specific performance test standards or consensus standards beyond ASTM F899.

The Innovasis instruments are substantially equivalent to the Globus ExcelsiusGPS predicate because they have identical critical dimensions, functionality, materials, and operational principles. Engineering analysis and geometric comparison demonstrate equivalent performance for accuracy. Biocompatibility was leveraged from additional predicate devices by the same manufacturer. Verification testing confirmed the subject instruments properly register with and fit within the navigation system hardware, establishing that they perform the same function as the predicate instruments when used with the ExcelsiusGPS platform.