510(k) · Cleared
ClearedScopis Hybrid Navigation System EM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scopis GmbH · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Feb 9, 2017 as substantially equivalent to K133573 (Fiagon GmbH, 2014) after a 253-day review. Its family tree reaches back 4 generations to 1994. 3 of the 17 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Feb 9, 2017
- Review
- 253 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911783 (1994). 13 ancestors in all, the oldest K871046 (1987). 3 later devices descend from it, 3 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 3 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 2 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 1 generation backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- This deviceK161491 Scopis Hybrid Navigation System EMScopis GmbH · 2017
- Descendant · cites it directly · 1 of its ownK193118 TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020
- Descendant · cites it directly · 0 of its ownK221098 Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning…Stryker Corporation · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK193502 TGS Universal Headrest with Mounting ArmStryker Ent · 2020
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K193118TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020 · cites it directly1descendant
- K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation · 2022 · cites it directly0descendants
- K193502TGS Universal Headrest with Mounting ArmStryker Ent · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −3 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −2 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −1 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| 0 (this device) | K161491 | Scopis Hybrid Navigation System EM | Scopis GmbH | 2017 | — |
| +1 | K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020 | — |
| +1 | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software… | Stryker Corporation | 2022 | 1 |
| +1 | K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | 2020 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K133573 | Fiagon Navigation SystemSummary page 4…dicate: Predicate Device Manufacturer 510(k) No.: Fiagon Navigation System Fiagon GmbH K133573 Page 40 vertraulich /… | 2014 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 13 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K193118 (Stryker Ent, 2020) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K133573.
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. 2017, 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 Scopis Hybrid Navigation System EM 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 the following ENT procedures:
• Transsphenoidal 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 as stated in the FDA summary.
https://510kreport.com/device/K161491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161491: Scopis Hybrid Navigation System EM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161491
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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