# K190881: Spinal Elements Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Dec 19, 2019 after 259 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: 16 generations back to K040583 (2004). 152 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K222516: Mercury® II Spinal System (2022), 3 descendants of its own
- K243916: Primus Spinal Fixation System (2025), 2 descendants of its own
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (2025), 1 descendant of its own
- K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (2026), 0 descendants of its own

## Indications for use
Spinal Elements Navigated Instruments are intended to be used during the preparation and placement of Spinal Elements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) 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 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/K190881
Methodology: https://510kreport.com/methodology