# K252087: Navigation Module of the Cortium® System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA, Inc.
- Decided: Feb 3, 2026 after 216 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: 18 generations back to K040583 (2004). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6.
- K170679: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems, Medtronic Sofamor Danek (2017) Summary page 6.

## Indications for use
The Navigation Module of the Cortium® System is intended to be used during the preparation and placement of Cortium® Universal OCT Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures. The Navigation Module of the Cortium® System is 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks for the anatomy. Instruments of the Navigation Module of the Cortium® System are not intended for navigation of occipital screws.

Source page: https://510kreport.com/device/K252087
Methodology: https://510kreport.com/methodology