OptiVu™ Shoulder

OptiVu Shoulder is a stereotaxic surgical navigation system using augmented reality (AR) head-mounted display and optical tracking to aid surgeons in locating anatomical structures, performing humerus resection, and aligning implants during total or reverse shoulder arthroplasty. It works with Zimmer Biomet shoulder implant systems and requires preoperative CT imaging for anatomical landmark identification.

The subject device uses a double sterile barrier packaging (versus single sterile barrier in predicate), but maintains identical stainless steel and Makrolon materials, same gamma irradiation sterilization method, equivalent AR/HMD technology, optical tracking system, and identical indications for use and device function compared to predicate K250108.

Not stated in this summary. The document references validation testing conducted according to written protocols with acceptance criteria based on established standards, but does not cite specific ISO, IEC, or ASTM standards by number.

The subject device is substantially equivalent because the only changes from the predicate are packaging configuration (double versus single sterile barrier) and sterilization site location. Validation testing confirmed no impact on sterilization efficacy or packaging safety. All other characteristics—regulatory class, product code, materials, design, performance, and indications for use—remain identical, and there are no new safety or efficacy questions raised by the packaging modifications.