# K251943: Spineology Navigation Instruments

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Dec 4, 2025 after 163 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: 22 generations back to K040583 (2004). 161 ancestors in all.
No later device cites it as a predicate yet.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213876: Spineology Navigation Instruments, Spineology, Inc. (2022) Summary page 5.

## Indications for use
Spineology Navigation Instruments are indicated for use during the preparation and placement of: • Spineology's Fortress, Threshold, Threshold V2, and Palisade pedicle screws • Spineology's OptiMesh® Portal Assembly during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures. These instruments are designed for use with the Medtronic StealthStation® Spine 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 the spine or pelvis, can be identified relative to images of the anatomy.

Source page: https://510kreport.com/device/K251943
Methodology: https://510kreport.com/methodology