ARVIS® Shoulder

The ARVIS® Shoulder is a Class II computer-controlled stereotaxic navigation system designed to enhance surgical precision in total shoulder arthroplasty. It achieves this by providing augmented reality visualization and enabling accurate intraoperative measurements and implant positioning based on preoperative imaging data.

Kico Knee Innovation Company Pty Ltd's ARVIS® Shoulder device has received regulatory clearance, being determined substantially equivalent to legally marketed devices. Classified as a Class II stereotaxic instrument, its primary indication is to assist surgeons in the precise positioning and alignment of implants during stereotactic orthopedic surgery, specifically for total shoulder arthroplasty. This system is designed to enhance accuracy relative to reference axes and anatomical landmarks. The ARVIS® Shoulder functions as a computer-controlled navigation system, providing surgeons with capabilities for intraoperative measurements and localization of anatomical structures based on the patient's preoperative imaging. It incorporates an innovative head-mounted ARVIS® Eyepiece for augmented reality visualization and real-time information display. The device's core technological principles, main system components, and navigation tracking technology are consistent with previously reviewed devices, and its compatibility has been broadened to support additional implant systems. Marketing is permitted contingent on adherence to ongoing regulatory standards.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific clinical data or studies support the claim of substantial equivalence and demonstrate improved surgical outcomes or reduced complications with the ARVIS® Shoulder system?; How does the integration of the head-mounted ARVIS® Eyepiece for augmented reality visualization compare in terms of accuracy and surgeon workflow to other existing navigation systems for shoulder arthroplasty?; What are the system's limitations regarding patient anatomy, surgical complexity, or operating room environment that might affect its performance or applicability?; What is the required training and learning curve for surgeons to effectively utilize the ARVIS® Shoulder system, particularly concerning its augmented reality features?; How does the expanded compatibility with additional implant systems impact the device's versatility and adoption across different surgical practices and what validation was performed for these new compatibilities?