# K260329: Ion-C Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: May 22, 2026 after 112 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: 21 generations back to K003155 (2001). 356 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240625: CORUS Navigation Access System, Providence Medical Technology, Inc. (2024) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K262121: Ion-L Navigated Instruments (2026), 0 descendants of its own

## Indications for use
The ION-C Navigation Instruments are intended to be used with the ION-C System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, 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 the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement.

Source page: https://510kreport.com/device/K260329
Methodology: https://510kreport.com/methodology