# K201569: CUVIS-spine

- Pathway: 510(k) (Traditional)
- Applicant: Curexo, Inc.
- Decided: May 19, 2021 after 342 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: 19 generations back to K040583 (2004). 427 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 430 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K223558: CUVIS-spine (2023), 0 descendants of its own
- K222698: CUVIS-spine (2022), 0 descendants of its own

## Indications for use
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.

Source page: https://510kreport.com/device/K201569
Methodology: https://510kreport.com/methodology