# K243950: ARVIS® Shoulder

- Pathway: 510(k) (Special)
- Applicant: Kico Knee Innovation Company Pty, Ltd.
- Decided: Jan 13, 2025 after 21 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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: 17 generations back to K983831 (1999). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240062: ARVIS® Shoulder, Insight Medical Systems, Inc. (2024) 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
- Sep 19, 2025 · Class II · Z-0145-2026: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

## 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. The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. 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. ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate, LimaCorporation PRIMA, and LimaCorporation SMR implant systems.

Source page: https://510kreport.com/device/K243950
Methodology: https://510kreport.com/methodology