iGPS Navigation Instruments

The iGPS Navigation Instruments are reusable surgical instruments designed for use with the Globus ExcelsiusGPS Robotic Navigation System to assist surgeons in placing iFuse TORQ and iFuse Bedrock Granite implants in sacroiliac joint fusion and spinal procedures. The instruments work with the robotic navigation system to precisely locate anatomical structures using CT, MR, or fluoroscopic imaging.

The iGPS instruments are dimensionally and functionally compatible with Globus ExcelsiusGPS robotic navigation instruments. They are navigated and reusable instrumentation designed to integrate with the Globus ExcelsiusGPS Robotic Navigation System and Instrument Trackers, enabling spatial positioning and orientation of instrument holders or guide tubes for open or percutaneous surgical procedures.

Not stated in this summary.

The devices are substantially equivalent because they have the same intended use as the predicate devices (ExcelsiusGPS and E-GPS instruments)—to assist surgeons in anatomically locating structures during navigation-guided implant placement—and use identical technological principles and materials. The differences in indications for use between the subject device and predicates (supporting different implant systems) are not critical to the core navigational function, and performance testing including dimensional comparison, bench testing, and simulated use testing demonstrated equivalence to the predicate.