# K180690: Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 25, 2018 after 101 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). 289 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K183119: SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments (2019), 2 descendants of its own
- K203153: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS (2021), 1 descendant of its own
- K183381: Navigation Enabled Instruments (2019), 1 descendant of its own
- K182000: AQrate Robotic Assistance System (2019), 1 descendant of its own
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own

## Indications for use
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) 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/K180690
Methodology: https://510kreport.com/methodology