NextAR Hip Platform

The NextAR Hip Platform is a computer-assisted surgical navigation system that supports surgeons during total hip arthroplasty procedures by providing real-time navigational guidance for bone preparation and acetabular cup positioning in skeletally mature patients. The system uses infrared tracking technology with markers mounted on bones and surgical instruments, allowing surgeons to visualize surgical planning information on a monitor and optionally on smart glasses.

The device shares power source, user interface, imaging modalities, surgical workflow, and registration/planning features with predicate devices. It differs in tracking technology (active versus passive markers), inclusion of head-mounted smart glasses display, and additional surgical guidance features for leg length and lateral offset assessment.

Not stated in this summary.

The subject device is substantially equivalent to predicate devices because the differences in tracking technology and smart glasses availability do not introduce new safety or effectiveness concerns, as these features are demonstrated in a reference device. Software verification and validation, cadaver testing, and in vitro accuracy testing confirm the subject platform is equivalent to conventional instrumentation and that the instruments are adequate for their intended use.