510(k) · Cleared
Recalled · Class II · 2018Rosa Surgical Device
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 Sep 23, 2010 as substantially equivalent to K092239 (Medtech S.A, 2009) and 3 other predicates after an 87-day review. Its family tree reaches back 5 generations to 2000. 5 of the 146 devices in its family, counting itself, have a Class I recall. 126 later devices descend from it. It has been recalled 12 times.
- Decided
- Sep 23, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 12
- Predicates
- 4
Its longest line of descent runs back 5 generations to K002053 (2000). 19 ancestors in all, the oldest K811452 (1981). 126 later devices descend from it, 4 citing it directly. 5 of the 146 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 4 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 3 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 2 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 1 generation backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- This deviceK101791 Rosa Surgical DeviceMedtech S.A.S · 2010
- Descendant · cites it directly · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 4 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
Showing 5 of 126 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 126 · See all- K151511ROSA SpineMedtech S.A · 2016 · cites it directly109descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 2 generations on29descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −4 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −3 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −2 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −1 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| 0 (this device) | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | — |
| +1 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| +2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +3 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +2 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +4 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
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 |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K092239 | Rosa Surgical Device, Model Rosa 1.1Summary page 1…HAW), 21 CFR Section 882.4560 classification name 3 Predicate devices ROSA Surgical Device, manufactured by MedTech SAS, K092239, cleared November 17, 2009 StealthStation Treatment Guidance Platform, manufactured by… | 2009 |
| * | K001801 | Steathstation Treatment Guidance PlatformSummary page 1…09 StealthStation Treatment Guidance Platform, manufactured by Medtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000 VectorVision Cranial / ENT, manufactured by… | 2000 |
| * | K023651 | Vectorvision Cranial/EntSummary page 1…ared June 30, 2000 VectorVision Cranial / ENT, manufactured by BrainLAB AG, K023651, cleared February 17, 2004 Frameless Neuromate Stereotactic System, manufactured by… | 2004 |
| * | K991081 | Frameless NeuromateSummary page 1…ruary 17, 2004 Frameless Neuromate Stereotactic System, manufactured by Integrated Surgical Systems, Inc., K991081, cleared June 25, 1999 4 Description ROSA Surgical Device is a computer con… | 1999 |
What descends from it? (126)
See all 1264 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2018 | Class II | Z-2108-2018 | No Marketing Application | Replacement of units lacking an updated device approval. |
| May 27, 2016 | Class II | Z-0105-2018 | Process control | Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. |
| Apr 8, 2016 | Class II | Z-0115-2018 | Software design | Potential for software to change the final tool orientation for the command position without command. |
| 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 12 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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K151511 (Medtech S.A, 2016) has gone furthest, with 109 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 fidlucial markers or optical 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/K101791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101791: Rosa Surgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101791
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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