NextAR(TM) Spine

The NextAR Spine is a CT-based computer-assisted surgical navigation platform for spine procedures using stereotaxic technology. It helps surgeons precisely locate anatomical structures and plan pedicle screw and sacro-iliac screw placement in open, mini-open, or percutaneous spine surgery, and includes a rod planning tool for fixation selection.

The device shares with its predicate: principle of stereotaxic operation, user interface, power source, optical tracking system, platform architecture, displaying technology, augmented reality glasses communication, surgical instruments for navigation, computer hardware, pre- and intra-operative imaging acquisition, rod planning and intra-operative screw planning features, fiducial registration accuracy, and instrument materials and sterility.

Not stated in this summary.

The subject device is substantially equivalent because it operates on identical stereotaxic principles with the same core system components and technological characteristics as the predicate K233172. The main difference—ability to navigate new instruments and use new target mountings—does not create a new risk or intended use, as these new instruments are substantially equivalent to instruments already cleared in predicate K210859. Biocompatibility uses identical materials and manufacturing to previously cleared instruments. Non-clinical verification through software testing, comparative evaluations, and cadaver workshops confirmed functional equivalence without requiring clinical data.