# K240625: CORUS Navigation Access System

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: May 3, 2024 after 58 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 K003155 (2001). 330 ancestors in all.
4 later devices descend from it; 3 cite it directly.
4 of 335 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211441: Navigated Anterolateral Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 4.
- K212636: CORUS Spinal System-X, Providence Medical Technology, Inc. (2021) Summary page 4.
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K260329: Ion-C Navigation Instruments (2026), 1 descendant of its own
- K262121: Ion-L Navigated Instruments (2026), 0 descendants of its own
- K251060: CORUS™ Navigation System-GX (2025), 0 descendants of its own
- K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (2025), 0 descendants of its own

## Indications for use
The CORUS™ Navigation Access System 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 Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K240625
Methodology: https://510kreport.com/methodology