ExcelsiusGPS® Instruments

ExcelsiusGPS® Instruments are navigated surgical instruments including drivers, drills, taps, and probes used to prepare implant sites or implant devices. The instruments work with ExcelsiusGPS® or ExcelsiusHub™ systems to aid surgeons in precisely locating anatomical structures and spatially positioning instrument guides for spinal and orthopedic bone screw placement in open or percutaneous procedures.

The subject instruments have the same or similar technological characteristics as predicate instruments including design, intended use, material composition, function, and range of sizes. The instruments differ only in tip geometries and dimensions to accommodate different spinal screws, which are minor modifications that do not raise new safety or effectiveness concerns.

Not stated in this summary.

The ExcelsiusGPS® instruments are substantially equivalent because they maintain identical core design, function, and material composition as the predicate devices while differing only in minor dimensional specifications for tip geometry needed to work with additional spinal screw types. Performance testing including instrument integration verification and biocompatibility assessment using predicate materials confirms the subject instruments meet performance requirements and can be used according to the same indications for use.