510(k) · Cleared
Recalled · Class II · 2024Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Jul 12, 2022 as substantially equivalent to K193118 (Stryker Ent, 2020) and 1 other predicate after an 89-day review. Its family tree reaches back 8 generations to 1994. 4 of the 30 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jul 12, 2022
- Review
- 89 days
- Class
- Class II
- Product code
- PGW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911783 (1994). 29 ancestors in all, the oldest K871046 (1987). No later device cites it as a predicate yet. 4 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 6 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 5 generations backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- 4 generations backK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- 3 generations backK160369 GuideWireFiagon GmbH · 2016
- 2 generations backK161940 Guidewire 0.6 Single UseFiagon GmbH · 2016
- 1 generation backK193118 TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020
- This deviceK221098 Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning…Stryker Corporation · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −6 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −5 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| −4 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| −3 | K160369 | GuideWire | Fiagon GmbH | 2016 | — |
| −2 | K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016 | — |
| −1 | K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020 | — |
| 0 (this device) | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software… | Stryker Corporation | 2022 | — |
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 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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.
4 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 |
|---|---|---|---|
| * | K193118 | TGS Guidewire and updated Scopis SoftwareSummary page 4…ereotaxic Instrument Legally Marketed Predicate Device Predicate Device Name TGS Guidewire and updated Scopis ENT and 510(k) Number Software (K193118) - Scopis ENT Software - Scopis ENT Software with TGS… | 2020 |
| * | K161491 | Scopis Hybrid Navigation System EMSummary page 4…- Scopis ENT Software - Scopis ENT Software with TGS Scopis Hybrid Navigation System EM (K161491) - Electromagnetic Navigation Unit Traditional 510(k) K221098 Scopis Softwa… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2024 | Class II | Z-1885-2024 | Software Manufacturing/Software Deployment | Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction. |
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 29 ancestors have a recall of any class; 4 have a Class I recall.
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. 2022, 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 Stryker ENT 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 the following 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 based 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/K221098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221098: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221098
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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