# K172444: ROSA BRAIN (v3.0.0.5)

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A
- Decided: Mar 28, 2018 after 226 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002053 (2000). 21 ancestors in all.
14 later devices descend from it; 1 cites it directly.
4 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151359: ROSA Brain, Medtech S.A (2015) Summary page 4.

## Most influential descendants
- K182417: ROSA ONE Brain Application (2019), 13 descendants of its own
- K200047: ExcelsiusGPS Cranial 1.0 Module (2020), 5 descendants of its own
- K200511: ROSA ONE Brain application (2020), 5 descendants of its own
- K231850: QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (2024), 2 descendants of its own
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own

## Recalls of this device
- Jan 6, 2020 · Class II · Z-1151-2020: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially co
- Jan 6, 2020 · Class II · Z-1150-2020: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially co
- Sep 10, 2019 · Class I · Z-0172-2020: The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
- May 1, 2017 · Class II · Z-0638-2018: Robot arm being sent to the wrong position

## Indications for use
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

Source page: https://510kreport.com/device/K172444
Methodology: https://510kreport.com/methodology