510(k) · Cleared
ClearedROSA ONE Brain Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtech S.A.S · HAW Neurological Stereotaxic Instrument
Cleared on Jul 20, 2023 as substantially equivalent to K214065 (Medtech S.A.S, 2022) after a 92-day review. Its family tree reaches back 11 generations to 2000. 4 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 20, 2023
- Review
- 92 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K002053 (2000). 25 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 4 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 7 generations between
- 3 generations backK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- 2 generations backK200511 ROSA ONE Brain applicationMedtech S.A · 2020 · Recalled (Class I)
- 1 generation backK214065 ROSA ONE Brain applicationMedtech S.A.S · 2022
- This deviceK231103 ROSA ONE Brain ApplicationMedtech S.A.S · 2023
Show all 11 generations
- Root · 11 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 10 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 9 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 8 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 7 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 6 generations backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- 5 generations backK151359 ROSA BrainMedtech S.A · 2015 · Recalled (Class I)
- 4 generations backK172444 ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Recalled (Class I)
- 3 generations backK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- 2 generations backK200511 ROSA ONE Brain applicationMedtech S.A · 2020 · Recalled (Class I)
- 1 generation backK214065 ROSA ONE Brain applicationMedtech S.A.S · 2022
- This deviceK231103 ROSA ONE Brain ApplicationMedtech S.A.S · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −10 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −9 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −8 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −7 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −6 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| −5 | K151359 | ROSA Brain | Medtech S.A | 2015 | Class I |
| −4 | K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | 2018 | Class I |
| −3 | K182417 | ROSA ONE Brain Application | Medtech S.A | 2019 | Class I |
| −2 | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | Class I |
| −1 | K214065 | ROSA ONE Brain application | Medtech S.A.S | 2022 | — |
| 0 (this device) | K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214065 | ROSA ONE Brain applicationSummary page 4…Product Code: HAW 510k #: K231103 III PREDICATE DEVICES ROSA ONE Brain application, manufactured by Medtech S.A.S, K214065, cleared on May 4, 2022 K231103… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K151359ROSA BrainMedtech S.A · 2015 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 25 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231103: ROSA ONE Brain Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231103
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026