510(k) · Cleared
ClearedStryker Essx with Navigation Mount
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Oct 2, 2008 as substantially equivalent to K011381 (Stryker Instruments, 2001) and 2 other predicates after a 268-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Oct 2, 2008
- Review
- 268 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K020594 (2002). 5 ancestors in all, the oldest K002224 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020594 | Diego Powered Dissector and Drill System | Gyrus Ent LLC | 2002 | — |
| −1 | K030343 | Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting… | Gyrus Ent LLC | 2003 | — |
| 0 (this device) | K080052 | Stryker Essx with Navigation Mount | Stryker Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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.
Planning a device in ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K011381 | Hummer IV Microdebrider System | 2001 |
| * | K030343 | Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting InterfaceSummary page 1…al, ENT (electric or pneumatic) including Handpiece Equivalent to: K0I 1381 Stryker Hummer IV MicroDebrider System K030343 Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface… | 2003 |
| * | K041523 | XPS 3000 SystemSummary page 1…K030343 Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface K041 523 XPS 3000 System Device Description:- The Stryker ES8x with Navigation Mount is an electric, high-speed… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K011381.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080052: Stryker Essx with Navigation Mount.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080052
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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