510(k) · Cleared
Recalled · 2007Vectorvision Cranial/Ent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Feb 17, 2004 as substantially equivalent to K983831 (Brainlab AG, 1999) and 1 other predicate after a 475-day review. Its family tree reaches back 1 generation to 1999. 6 of the 151 devices in its family, counting itself, have a Class I recall. 148 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 2004
- Review
- 475 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983831 (1999). 2 ancestors in all. 148 later devices descend from it, 5 citing it directly. 6 of the 151 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK983831 VECTORVISION2Brainlab AG · 1999
- This deviceK023651 Vectorvision Cranial/EntBrainlab AG · 2004
- 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 148 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 148 · 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 |
|---|---|---|---|---|---|
| −1 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| 0 (this device) | K023651 | Vectorvision Cranial/Ent | Brainlab AG | 2004 | — |
| +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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 10 | 1 |
| 2020 | 5 | 1 |
| 2021 | 10 | 1 |
| 2022 | 12 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 29 | 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.
6 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 |
|---|---|---|---|
| * | K983831 | VECTORVISION2Summary page 1…NT Common/Classification Name: Image Guided Surgery System, CAS /Stereotaxy Instrument Predicate Device: Vector Vision® 2 (K 983831) VectorVision Cranial / ENT / Spine (K003589) Device Classification Name: Stereotaxy Instrument Regulatory Class: Class 11 Ind… | 1999 |
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntSummary page 1…Guided Surgery System, CAS /Stereotaxy Instrument Predicate Device: Vector Vision® 2 (K 983831) VectorVision Cranial / ENT / Spine (K003589) Device Classification Name: Stereotaxy Instrument Regulatory Class: Class 11 Indications For Use: VectorVision Cranial/ENT is… | 2001 |
What descends from it? (148)
See all 1485 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2007 | Not classified | Z-2209-2008 | Component design/selection | Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in… |
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.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- 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
Nearest 5 of 6; all are on the web page.
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?
VectorVision Cranial/ENT is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on patient image data being processed by the VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical…
Read the full statement (140 words)
VectorVision Cranial/ENT is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on patient image data being processed by the VectorVision workstation.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.
Example procedures include but are not limited to:
Cranial Procedures:
Cranial biopsies
Tumor resections
Craniotomies/ Craniectomies
Skull base procedures
Thalamotomies/Pallidotomies
ENT Procedures:
Transphenoidal procedures
Intranasal procedures
Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies / Sphenoid explorations, Turbinate resections and Frontal sinusotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023651: Vectorvision Cranial/Ent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023651
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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