510(k) · Cleared
ClearedNeuromate Stereotactic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Surgical Systems, S.A. · HAW Neurological Stereotaxic Instrument
Cleared on May 9, 1997 as substantially equivalent to K811452 (Trent Wells, Inc., 1981) and 1 other predicate after a 263-day review. Its family tree reaches back 1 generation to 1981. 5 of the 185 devices in its family, counting itself, have a Class I recall. 182 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 263 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811452 (1981). 2 ancestors in all. 182 later devices descend from it, 3 citing it directly. 5 of the 185 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- This deviceK963256 Neuromate Stereotactic SystemIntegrated Surgical Systems, S.A. · 1997
- Descendant · cites it directly · 180 of its ownK991081 Frameless NeuromateIntegrated Surgical Systems, Inc. · 1999
- Descendant · cites it directly · 128 of its ownK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- Descendant · 2 generations on · 127 of its ownK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- Descendant · 2 generations on · 126 of its ownK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- Descendant · 3 generations on · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 182 · See all- K991081Frameless NeuromateIntegrated Surgical Systems, Inc. · 1999 · cites it directly180descendants
- K060556Brigit Surgical DeviceZimmer, Inc. · 2006 · cites it directly128descendants
- K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · 2 generations on127descendants
- K101791Rosa Surgical DeviceMedtech S.A.S · 2010 · 2 generations on126descendants
- K151511ROSA SpineMedtech S.A · 2016 · 3 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| 0 (this device) | K963256 | Neuromate Stereotactic System | Integrated Surgical Systems, S.A. | 1997 | — |
| +1 | K991081 | Frameless Neuromate | Integrated Surgical Systems, Inc. | 1999 | — |
| +1 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| +2 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| +2 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| +3 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 1 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 1 |
| 2019 | 11 | 1 |
| 2020 | 7 | 1 |
| 2021 | 10 | 1 |
| 2022 | 11 | 0 |
| 2023 | 23 | 0 |
| 2024 | 21 | 0 |
| 2025 | 29 | 0 |
| 2026 | 29 | 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? (2)
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 |
|---|---|---|---|
| * | K811452 | Brown-Roberts-Wells Stereotaxic SytemSummary page 1…The NeuroMate Stereotactic System is substantially equivalent to the following previously cleared and currently marketed devices: ¢ BRW Stereotactic System (Radionics; K811452) COMPASS Stereotactic System (Stereotactic Medical Systems; K871048) D. Device Description The NeuroMate Stereotactic System is… | 1981 |
| * | K871046 | Compass Stereotactic Positioning System Our OCR of the scanned summary read K871048, FDA’s number for Micro Mammo I Mammography Unit (Amerasia Import-Export, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “COMPASS Stereotactic System”. | 1987 |
What descends from it? (182)
See all 1823 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)
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.
- K151359ROSA BrainMedtech S.A · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 NeuroMate Stereotactic System, the BRW Stereotactic System and the Compass Stereotactic Systems are intended for the stereotactic spatial positioning and orientation of an instrument or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963256: Neuromate Stereotactic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963256
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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