# K203115: ARVIS Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Insight Medical Systems, Inc.
- Decided: Jul 14, 2021 after 271 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K983831 (1999). 52 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172462: OrthAlign Plus System, Orthalign, Inc. (2017) Summary page 4.

## Most influential descendants
- K240062: ARVIS® Shoulder (2024), 1 descendant of its own
- K243980: ARVIS Surgical Navigation System (2025), 0 descendants of its own
- K243950: ARVIS® Shoulder (2025), 0 descendants of its own

## Recalls of this device
- Apr 23, 2026 · Class II · Z-2293-2026: The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
- Apr 23, 2026 · Class II · Z-2292-2026: The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

## 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 » Unicompartmental Knee Arthroplasty: Tibial Transverse Resection * Hip Arthroplasty

Source page: https://510kreport.com/device/K203115
Methodology: https://510kreport.com/methodology