510(k) · Cleared
ClearedInstrument Clamps Electromagnetic
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 Oct 9, 2020 as substantially equivalent to K171661 (Scopis GmbH, 2017) after a 30-day review. Its family tree reaches back 6 generations to 1999. 4 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 9, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983831 (1999). 25 ancestors in all, the oldest K871046 (1987). No later device cites it as a predicate yet. 4 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 3 generations backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- 2 generations backK092467 Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri…Brainlab AG · 2010 · Recalled (Class I)
- 1 generation backK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- This deviceK202609 Instrument Clamps ElectromagneticStryker Corporation · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −3 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| −2 | K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial… | Brainlab AG | 2010 | Class I |
| −1 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| 0 (this device) | K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 1 |
| 1997 | 1 | 0 |
| 1998 | 2 | 2 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 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? (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 |
|---|---|---|---|
| * | K171661 | Scopis Extended Instrument Set EMSummary page 4…nt Set EM Instrument Clamps Universal Tracker Electromagnetic Predicate Device 510(k) Number K171661 Special 510(k) K202609 Instrument Clamps Electromagnetic The Scopis Extended Instrument Set EM was cleared unde… | 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)
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.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 8 of the 25 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K171661.
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. 2020, 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 Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments. 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…
Read the full statement (122 words)
The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments.
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/K202609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202609: Instrument Clamps Electromagnetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202609
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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