510(k) · Cleared
ClearedFrameless Neuromate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Surgical Systems, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 25, 1999 as substantially equivalent to K963256 (Integrated Surgical Systems, S.A., 1997) after an 86-day review. Its family tree reaches back 2 generations to 1981. 5 of the 184 devices in its family, counting itself, have a Class I recall. 180 later devices descend from it.
- Decided
- Jun 25, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811452 (1981). 3 ancestors in all. 180 later devices descend from it, 6 citing it directly. 5 of the 184 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 1 generation backK963256 Neuromate Stereotactic SystemIntegrated Surgical Systems, S.A. · 1997
- This deviceK991081 Frameless NeuromateIntegrated Surgical Systems, Inc. · 1999
- Descendant · cites it directly · 127 of its ownK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 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
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 180 · See all- K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · cites it directly127descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −1 | K963256 | Neuromate Stereotactic System | Integrated Surgical Systems, S.A. | 1997 | — |
| 0 (this device) | K991081 | Frameless Neuromate | Integrated Surgical Systems, Inc. | 1999 | — |
| +1 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| +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 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K963256 | Neuromate Stereotactic SystemSummary page 1…L SYSTEMS SUMMARY OF SAFETY AND EFFECTIVENESS 1.0 DEVICE NAME (Trade, common, and classification). Frameless NeuroMate Stereotactic System. ‘ 2.0 PREDICATE DEVICE(s): K963256. 3.0 DESCRIPTION: A stereotactic system with an electromechanical, multijointed arm for spatial positioning and orientation of a… | 1997 |
What descends from it? (180)
See all 1806 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 · 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 18 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092239 (Medtech S.A, 2009) has gone furthest, with 127 descendants of its own.
- 2 other devices also cite its predicate K963256.
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?
Stereotactic spatial positioning and orientation of an instrument holder 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/K991081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991081: Frameless Neuromate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991081
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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