# K230567: OptiVu™ ROSA® MxR

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
- Decided: Jun 13, 2023 after 104 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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: 15 generations back to K905070 (1991). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220733: OptiVu ROSA MxR, Orthosoft Inc (D/B/A Zimmer Cas) (2022) Summary page 4.

## Indications for use
OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

Source page: https://510kreport.com/device/K230567
Methodology: https://510kreport.com/methodology