510(k) · Cleared
ClearedCube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiagon GmbH · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Jul 19, 2021 as substantially equivalent to K162176 (Fiagon GmbH, 2016) and 1 other predicate after an 82-day review. Its family tree reaches back 5 generations to 1994. 3 of the 16 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 19, 2021
- Review
- 82 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K911783 (1994). 14 ancestors in all, the oldest K871046 (1987). 1 later device descends from it, 1 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 3 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 2 generations backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- 1 generation backK162176 Fiagon Navigation SystemFiagon GmbH · 2016
- This deviceK211291 Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest…Fiagon GmbH · 2021
- Descendant · cites it directly · 0 of its ownK261540 Cube 4D Navigation System, VirtuEye ProFiagon GmbH · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −3 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −2 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| −1 | K162176 | Fiagon Navigation System | Fiagon GmbH | 2016 | — |
| 0 (this device) | K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation… | Fiagon GmbH | 2021 | — |
| +1 | K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 1 |
| 1998 | 2 | 2 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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.
3 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 PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 12.9 · 6 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 |
|---|---|---|---|
| * | K162176 | Fiagon Navigation SystemSummary page 4…PGW 3. Predicate Device Information The Cube navigation system is substantially equivalent to the following predicate devices: • Fiagon Navigation system (K162176) - primary • Fiagon Navigation system (K133573) – secondary 4. Device Description The Cube Navigation System is an image gu… | 2016 |
| * | K133573 | Fiagon Navigation SystemSummary page 4…Cube navigation system is substantially equivalent to the following predicate devices: • Fiagon Navigation system (K162176) - primary • Fiagon Navigation system (K133573) – secondary 4. Device Description The Cube Navigation System is an image guided surgery system, visualizing instrument position… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye Pro | 2026 | 0 |
Has anything in its family been recalled? (3 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.
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 14 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K261540 (Fiagon GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162176.
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
The Cube Navigation System and its components are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Cube Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR…
Read the full statement (113 words)
The Cube Navigation System and its components are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Cube Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures
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/K211291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211291: Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211291
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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