# K240062: ARVIS® Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Insight Medical Systems, Inc.
- Decided: Apr 29, 2024 after 111 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- 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.
1 later device descends from it; 1 cites it directly.
0 of 55 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.

## Most influential descendants
- K243950: ARVIS® Shoulder (2025), 0 descendants of its own

## Indications for use
ARVIS® Shoulder 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 and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging. ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate implant system.

Source page: https://510kreport.com/device/K240062
Methodology: https://510kreport.com/methodology