# K231103: ROSA ONE Brain Application

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A.S
- Decided: Jul 20, 2023 after 92 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: 11 generations back to K002053 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
4 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214065: ROSA ONE Brain application, Medtech S.A.S (2022) Summary page 4.

## Indications for use
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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/K231103
Methodology: https://510kreport.com/methodology