510(k) · Cleared
Recalled · 2007Navigus II Trajectory Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image-Guided Neurologics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Oct 1, 2001 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK012366 Navigus II Trajectory GuideImage-Guided Neurologics, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK090240 Monteris Medical UfoMonteris Medical, · 2009
- Descendant · 2 generations on · 2 of its ownK180854 Voyager Trajectory Array Guide (V-TAG)Voyager Therapeutics, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK162604 Cranial Reducing TubesMedtronic Navigation, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK253663 Zeta Navigation SystemZeta Surgical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK250893 Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K090240Monteris Medical UfoMonteris Medical, · 2009 · cites it directly3descendants
- K180854Voyager Trajectory Array Guide (V-TAG)Voyager Therapeutics, Inc. · 2018 · 2 generations on2descendants
- K162604Cranial Reducing TubesMedtronic Navigation, Inc. · 2016 · cites it directly1descendant
- K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026 · 2 generations on0descendants
- K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012366 | Navigus II Trajectory Guide | Image-Guided Neurologics, Inc. | 2001 | — |
| +1 | K090240 | Monteris Medical Ufo | Monteris Medical, | 2009 | — |
| +2 | K180854 | Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. | 2018 | — |
| +1 | K162604 | Cranial Reducing Tubes | Medtronic Navigation, Inc. | 2016 | — |
| +2 | K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026 | — |
| +3 | K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2007 | Not classified | Z-0849-2008 | Package design/selection | Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090240 (Monteris Medical,, 2009) has gone furthest, with 3 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.
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 Navigus II Trajectory Guide is intended to
provide stereotactic guidance for the placement and operation of
instruments or devices during planning and operation of
neurological procedures performed in conjunction with the use of
an Image Guided Workstation System using preoperative MR
and/or CT imaging. These procedures include biopsies, catheter
placement and electrode introduction. The device is ETO sterilized
and for one time use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012366: Navigus II Trajectory Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012366
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026