ARVIS Surgical Navigation System
Kico Knee Innovation Company Pty LimitedThe ARVIS Surgical Navigation System assists surgeons during orthopedic surgeries by providing real-time, augmented reality-based visualization and precise intraoperative measurements to aid in positioning and aligning implants. It enhances surgical accuracy in procedures such as knee and hip arthroplasties, improving outcomes and helping surgeons make informed decisions during operations.
Intended Use
The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery and aids intraoperative measurements such as changes in leg length in Hip Arthroplasty.
Technology
The device combines software, electronic hardware mounted on the surgeon's head and waist, augmented reality head-mounted display, and surgical instruments to intraoperatively track tools and anatomical landmarks using preoperative imaging. The new version adds remote activation of graphical user interfaces to improve surgeon interaction.
Performance
Performance was demonstrated through software verification and validation tests, showing that the updated device is as safe and effective as the predicate device. Clinical testing was not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2024
2 months - 2
FDA Approval
3/21/2025
Other devices from Kico Knee Innovation Company Pty Limited
- ARVIS® Shoulder2025 • 510K
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