Altus Spine Navigation System

The Altus Spine Navigation System is a set of reusable surgical instruments (screwdrivers and taps) made of stainless steel, designed to work with the Medtronic StealthStation® System S8 navigation system. It assists surgeons in precisely locating anatomical structures during preparation and placement of pedicle screws in spinal surgery via open, minimally invasive, or percutaneous approaches for the Altus Spine Valencia and Monaco pedicle screw systems.

The device shares the same design principles, material composition (ASTM F899 stainless steel), functional length, NavLock® connection feature, intended use, function, and range of sizes as the predicate instruments. The subject instruments differ from the primary predicate only in tip geometries and dimensions to accommodate the spinal screws, which are minor differences that do not raise new safety or effectiveness concerns.

ASTM F2554 (recognition and location testing with the Medtronic StealthStation® System S8 navigation system) and ASTM F899 (stainless steel material specification).

The Altus Spine Navigation System operates on the same principle as the predicate device and was tested side-by-side with the primary predicate (Navigated CD Horizon® Solera® Screwdrivers and Taps). Dimensional accuracy and critical length comparisons demonstrated substantial equivalence in use and performance. The minor tip geometry and dimensional differences are necessary to accommodate different spinal screw designs but do not introduce new safety or effectiveness concerns relative to the predicate.