ARVIS® Shoulder

ARVIS® Shoulder is a computer-controlled navigation system for shoulder arthroplasty that assists surgeons in positioning and aligning implants during surgery. It uses preoperative CT imaging and intraoperative tracking to provide real-time guidance through an augmented reality head-mounted eyepiece display, helping surgeons locate anatomical structures and measure implant positioning for total shoulder replacement using compatible implant systems.

The subject device maintains the same operating principle, main system components, materials, and navigation tracking technology as the predicate device. The primary technological difference is expanded compatibility with additional implant systems (LimaCorporation PRIMA and SMR systems) beyond the predicate's original implant compatibility.

Not stated in this summary.

The device is substantially equivalent because it performs the same function as the predicate device using identical operating principles, components, and navigation tracking technology. The only difference—extended implant system compatibility—does not change the device's intended use or fundamental operation; compatibility verification using established methods demonstrates the device maintains the same safety and effectiveness profile as the predicate device.