# K182000: AQrate Robotic Assistance System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 29, 2019 after 187 days
- Product code: HAW (Neurological 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: 19 generations back to K040583 (2004). 428 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 430 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.
- K180690: Navigation Instruments, Globus Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K240721: ExcelsiusFlex™ (2024), 0 descendants of its own

## Indications for use
The AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instruments and instrument guides 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. The system is indicated for the placement of spinal screws.

Source page: https://510kreport.com/device/K182000
Methodology: https://510kreport.com/methodology