510(k) · Cleared
Recalled · Class II · 2016Rosa Surgical Device, Model Rosa 1.1
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 Nov 17, 2009 as substantially equivalent to K991081 (Integrated Surgical Systems, Inc., 1999) and 2 other predicates after a 117-day review. Its family tree reaches back 4 generations to 2000. 5 of the 143 devices in its family, counting itself, have a Class I recall. 127 later devices descend from it. It has been recalled 9 times.
- Decided
- Nov 17, 2009
- Review
- 117 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002053 (2000). 15 ancestors in all, the oldest K811452 (1981). 127 later devices descend from it, 1 citing it directly. 5 of the 143 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 3 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 2 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 1 generation backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- This deviceK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009
- Descendant · cites it directly · 126 of its ownK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- Descendant · 2 generations on · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 127 · See all- K101791Rosa Surgical DeviceMedtech S.A.S · 2010 · cites it directly126descendants
- K151511ROSA SpineMedtech S.A · 2016 · 2 generations on109descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 4 generations on42descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −3 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −2 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −1 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| 0 (this device) | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | — |
| +1 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| +2 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +4 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +3 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 1 |
| 2019 | 9 | 1 |
| 2020 | 2 | 1 |
| 2021 | 8 | 1 |
| 2022 | 11 | 0 |
| 2023 | 19 | 0 |
| 2024 | 20 | 0 |
| 2025 | 27 | 0 |
| 2026 | 24 | 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.
5 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? (3)
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 |
|---|---|---|---|
| * | K991081 | Frameless NeuromateSummary page 1…lassification name 3 Predicate devices Frameless Neuromate Stereotactic System; manufactured by Integrated Surgical Systems, Inc., K991081, cleared June 25, 1999 StealthStation Treatment Guidance Platform, manu… | 1999 |
| * | K001801 | Steathstation Treatment Guidance PlatformSummary page 1…1999 StealthStation Treatment Guidance Platform, manufactured by Medtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000 BRIGIT Surgical Device, manufactured by Zimmer, In… | 2000 |
| * | K060556 | Brigit Surgical DeviceSummary page 1…K001801, cleared June 30, 2000 BRIGIT Surgical Device, manufactured by Zimmer, Inc., K060556, cleared July 31, 2006 4 Description ROSA Surgical Device is a computer controlled… | 2006 |
What descends from it? (127)
See all 1271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101791 | Rosa Surgical Device | 2010 | 126 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2016 | Class II | Z-3117-2017 | Software design | Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. |
| Nov 6, 2014 | Class II | Z-0160-2018 | Device Design | Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). |
| Sep 5, 2014 | Class II | Z-0184-2018 | Software design | The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. |
| Jun 4, 2014 | Class II | Z-0161-2018 | Software Design Change | Software corrections reactivating the cooperative endoscopy mode. |
| Feb 14, 2014 | Class II | Z-0102-2018 | Error in labeling | An undetected shift between the information displayed in the navigation software and the actual patient anatomy |
| Dec 18, 2013 | Class II | Z-0096-2018 | Device Design | Possible break in the connector of the Force Sensor. |
| Feb 10, 2013 | Class II | Z-0178-2018 | Software design | Issue with optional neuro-endoscopy module detected under specific conditions during internal testing. |
| Feb 5, 2013 | Class II | Z-0099-2018 | Device Design | Observed instability of the device. |
| Apr 19, 2012 | Class II | Z-0100-2018 | Device Design | Potential failure of the optical distance sensor due to cable disconnection. |
The 5 latest of 9 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.
- K151359ROSA BrainMedtech S.A · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K101791 (Medtech S.A.S, 2010) has gone furthest, with 126 descendants of its own.
- 5 other devices also cite its predicate K991081.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092239 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092239: Rosa Surgical Device, Model Rosa 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092239
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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