# K172518: Spineology Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Jan 5, 2018 after 137 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). 157 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K180796: Spineology Navigation Instruments (2018), 3 descendants of its own
- K182345: Spineology Navigation Instruments (2018), 2 descendants of its own
- K213876: Spineology Navigation Instruments (2022), 1 descendant of its own
- K251943: Spineology Navigation Instruments (2025), 0 descendants of its own

## Indications for use
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology’s Fortress, Threshold, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Source page: https://510kreport.com/device/K172518
Methodology: https://510kreport.com/methodology