# K153203: Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Feb 3, 2016 after 91 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.
112 later devices descend from it; 11 cite it directly.
1 of 265 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K211616: ExcelsiusHub (2021), 9 descendants of its own

## Indications for use
Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization 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 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.

Source page: https://510kreport.com/device/K153203
Methodology: https://510kreport.com/methodology