510(k) · Cleared
Recalled · Class I · 2021ROSA ONE Brain application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtech S.A · HAW Neurological Stereotaxic Instrument
Cleared on May 29, 2020 as substantially equivalent to K182417 (Medtech S.A, 2019) after an 88-day review. Its family tree reaches back 9 generations to 2000. 4 of the 29 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 29, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K002053 (2000). 23 ancestors in all, the oldest K811452 (1981). 5 later devices descend from it, 3 citing it directly. 4 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations between
- 3 generations backK151359 ROSA BrainMedtech S.A · 2015 · Recalled (Class I)
- 2 generations backK172444 ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Recalled (Class I)
- 1 generation backK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- This deviceK200511 ROSA ONE Brain applicationMedtech S.A · 2020
- Descendant · cites it directly · 1 of its ownK241333 Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK214065 ROSA ONE Brain applicationMedtech S.A.S · 2022
- Descendant · 2 generations on · 0 of its ownK253856 Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK231103 ROSA ONE Brain ApplicationMedtech S.A.S · 2023
- Descendant · cites it directly · 0 of its ownK220072 Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 8 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 7 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 6 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 5 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 4 generations backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- 3 generations backK151359 ROSA BrainMedtech S.A · 2015 · Recalled (Class I)
- 2 generations backK172444 ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Recalled (Class I)
- 1 generation backK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- This deviceK200511 ROSA ONE Brain applicationMedtech S.A · 2020
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2025 · cites it directly1descendant
- K214065ROSA ONE Brain applicationMedtech S.A.S · 2022 · cites it directly1descendant
- K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026 · 2 generations on0descendants
- K231103ROSA ONE Brain ApplicationMedtech S.A.S · 2023 · 2 generations on0descendants
- K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −8 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −7 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −6 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −5 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −4 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| −3 | K151359 | ROSA Brain | Medtech S.A | 2015 | Class I |
| −2 | K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | 2018 | Class I |
| −1 | K182417 | ROSA ONE Brain Application | Medtech S.A | 2019 | Class I |
| 0 (this device) | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | — |
| +1 | K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025 | — |
| +1 | K214065 | ROSA ONE Brain application | Medtech S.A.S | 2022 | — |
| +2 | K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026 | — |
| +2 | K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023 | — |
| +1 | K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K182417 | ROSA ONE Brain ApplicationSummary page 4…duct Code: HAW (Brain) 510k #: K200511 III PREDICATE DEVICES ROSA ONE Brain application, manufactured by Medtech S.A., K182417, cleared on February 7, 2019… | 2019 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2021 | Class I | Z-0118-2022 | Software design | 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 related to the issue. An incorrect… |
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.
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K151359ROSA BrainMedtech S.A · 2015 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 23 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K241333 (Koh Young Technology, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K182417.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K200511 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200511: ROSA ONE Brain application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200511
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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