# K182417: ROSA ONE Brain Application

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A
- Decided: Feb 7, 2019 after 155 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K002053 (2000). 22 ancestors in all.
13 later devices descend from it; 3 cite 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)
- K172444: ROSA BRAIN (v3.0.0.5), Medtech S.A (2018) Summary page 4.

## Most influential descendants
- 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
- K241333: Geniant Cranial (Navigated Neurosurgical Positioning Robot) (2025), 1 descendant of its own

## Recalls of this device
- Sep 22, 2021 · Class I · Z-0118-2022: The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints
- 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

## 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 neurosurgery may be appropriate.

Source page: https://510kreport.com/device/K182417
Methodology: https://510kreport.com/methodology