510(k) · Cleared
Recalled · Class I · 2020ROSA Brain
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 Dec 18, 2015 as substantially equivalent to K101791 (Medtech S.A.S, 2010) after a 212-day review. Its family tree reaches back 6 generations to 2000. 4 of the 41 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Dec 18, 2015
- Review
- 212 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 7 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002053 (2000). 20 ancestors in all, the oldest K811452 (1981). 20 later devices descend from it, 2 citing it directly. 4 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 4 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 3 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 2 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 1 generation backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- This deviceK151359 ROSA BrainMedtech S.A · 2015
- Descendant · cites it directly · 14 of its ownK172444 ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 13 of its ownK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 5 of its ownK200511 ROSA ONE Brain applicationMedtech S.A · 2020 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · cites it directly14descendants
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 2 generations on13descendants
- K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · 3 generations on5descendants
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 3 generations on5descendants
- K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −5 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −4 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −3 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −2 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −1 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| 0 (this device) | K151359 | ROSA Brain | Medtech S.A | 2015 | — |
| +1 | K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | 2018 | Class I |
| +2 | K182417 | ROSA ONE Brain Application | Medtech S.A | 2019 | Class I |
| +3 | K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020 | 3 |
| +3 | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | Class I |
| +1 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
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 |
|---|---|---|
| 2018 | 1 | 1 |
| 2019 | 2 | 1 |
| 2020 | 2 | 1 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K101791 | Rosa Surgical Device 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”. | 2010 |
What descends from it? (20)
See all 202 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 |
|---|---|---|---|---|
| Jan 6, 2020 | Class II | Z-1151-2020 | Software design | 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 compromising the surgery planning. |
| Jan 6, 2020 | Class II | Z-1150-2020 | Software design | 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 compromising the surgery planning. |
| Sep 10, 2019 | Class I | Z-0172-2020 | Software in the Use Environment | 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 | Component change control | Unapproved change made by the supplier. |
| Oct 11, 2016 | Class II | Z-2868-2017 | Process design | Complaint of the head holder connector locking up mechanically when tightened. |
| Jul 29, 2016 | Class II | Z-0116-2018 | Error in labeling | Non-conforming product label. |
| Jul 20, 2016 | Class II | Z-0167-2018 | Software design | Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller. |
The 5 latest of 7 recalls; the web page lists all.
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.
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K172444 (Medtech S.A, 2018) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K101791.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151359: ROSA Brain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151359
Report an extraction error
Are you the manufacturer?
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