# K261665: CORUS™ Navigation System-GN

- Pathway: 510(k) (Special)
- Applicant: Providence Medical Technology, Inc.
- Decided: Jun 18, 2026 after 29 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: 20 generations back to K040583 (2004). 686 ancestors in all.
No later device cites it as a predicate yet.
3 of 687 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 6.

## Indications for use
The CORUS™ Navigation System-GN for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GN is specifically designed for use with the Globus Medical ExcelsiusGPS™ which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Source page: https://510kreport.com/device/K261665
Methodology: https://510kreport.com/methodology