# K243980: ARVIS Surgical Navigation System

- Pathway: 510(k) (Special)
- Applicant: Kico Knee Innovation Company Pty Limited
- Decided: Mar 21, 2025 after 88 days
- Product code: SBF (Orthopedic Augmented Reality)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K983831 (1999). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203115: ARVIS Surgical Navigation System, Insight Medical Systems, Inc. (2021) Summary page 5.

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2957-2026: Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

## Indications for 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. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: • Total Knee Arthroplasty • Unicompartrnental Knee Arthroplasty: Tibial Transverse Resection • Hip Arthroplasty The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.

Source page: https://510kreport.com/device/K243980
Methodology: https://510kreport.com/methodology