NextAR(TM) Shoulder Platform

The NextAR Shoulder Platform is a CT-based computer-assisted surgical navigation system that assists surgeons during glenoid implantation in anatomic and reverse shoulder replacement procedures. It provides real-time information on bone preparation, instrument guidance, and implant positioning using stereotaxic technology with infrared tracking sensors and displays data on a screen monitor. Optional augmented reality glasses can display the same 2D stereotaxic information as an auxiliary display but must always be used with the primary computer display.

The device uses a PC-based hardware platform, optical tracking system, augmented reality glasses, navigation software displaying real-time information, and reusable surgical instruments. It operates on stereotaxic principles with infrared markers and cameras to track scapula and instrument position relative to preoperative CT data. Main components include power source, user interface, glasses communication, registration features, and planned/controlled parameters. Materials and sterility are equivalent to predicate devices.

Not stated in this summary.

The subject device is substantially equivalent to predicates K232280 and K210153 because it uses identical main system components, power source, user interface, glasses communication, registration features, and controlled parameters. The only difference is additional workflow steps for reverse shoulder arthroplasty, which are surgical steps substantially equivalent to existing ones in the predicate devices. Software verification and validation, cadaver workshops, and biocompatibility testing leveraging material equivalence to K232280 support this equivalence without introducing safety or performance differences.