# K151359: ROSA Brain

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A
- Decided: Dec 18, 2015 after 212 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002053 (2000). 20 ancestors in all.
20 later devices descend from it; 2 cite it directly.
4 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101791: Rosa Surgical Device, Medtech S.A.S (2010). Our reading of the summary gave K101797, FDA’s number for Sonicision Cordless Ultrasonic Dissection Device Model… (Covidien, Formerly Valleylab, A Division of Tyco). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ROSA Surgical Device”. Summary page 5.

## Most influential descendants
- K172444: ROSA BRAIN (v3.0.0.5) (2018), 14 descendants of its own
- 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
- K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System (2019), 4 descendants 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.
- Feb 27, 2017 · Class II · Z-1754-2017: Unapproved change made by the supplier.
- Oct 11, 2016 · Class II · Z-2868-2017: Complaint of the head holder connector locking up mechanically when tightened.
- Jul 29, 2016 · Class II · Z-0116-2018: Non-conforming product label.
- Jul 20, 2016 · Class II · Z-0167-2018: Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.

## 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/K151359
Methodology: https://510kreport.com/methodology