# K143628: Navigated Vertex Select Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Feb 12, 2015 after 52 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: 10 generations back to K862807 (1986). 63 ancestors in all.
206 later devices descend from it; 20 cite it directly.
1 of 270 devices in its family (counting itself) has 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 4.

## Most influential descendants
- K153203: Navigation Instruments (2016), 112 descendants of its own
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K172517: SeaSpine Navigation System (2018), 60 descendants of its own
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own

## Indications for use
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Instruments are specifically designed for use with the 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE™ System.

Source page: https://510kreport.com/device/K143628
Methodology: https://510kreport.com/methodology