510(k) · Cleared
ClearedFiagon Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiagon GmbH · HAW Neurological Stereotaxic Instrument
Cleared on Sep 14, 2017 as substantially equivalent to K151156 (Fiagon GmbH, 2016) and 2 other predicates after a 303-day review. Its family tree reaches back 4 generations to 2000. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 14, 2017
- Review
- 303 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K993239 (2000). 10 ancestors in all. No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 3 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 2 generations backK142024 Brightmatter Navigation SystemSynaptive Medical, Inc. · 2015 · Recalled
- 1 generation backK151156 Fiagon Navigation SystemFiagon GmbH · 2016
- This deviceK163209 Fiagon Navigation SystemFiagon GmbH · 2017
Class I recalls in this family
- K150216 Synergy Cranialdirect predicate · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −3 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −2 | K142024 | Brightmatter Navigation System | Synaptive Medical, Inc. | 2015 | 1 |
| −1 | K151156 | Fiagon Navigation System | Fiagon GmbH | 2016 | — |
| 0 (this device) | K163209 | Fiagon Navigation System | Fiagon GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 2 | 1 |
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.
1 device in this family has 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K151156 | Fiagon Navigation SystemSummary page 4…n: Class II per 21 CFR 882.4560 Device: Stereotaxic Instrument Product Code: HAW Predicate Devices • Fiagon Navigation System, Fiagon GmbH (K151156 – Primary Predicate) • StealthStation System with Synergy Cranial Software, Medtronic Navigation, Inc.… | 2016 |
| * | K150216 | Synergy CranialSummary page 4…gation System, Fiagon GmbH (K151156 – Primary Predicate) • StealthStation System with Synergy Cranial Software, Medtronic Navigation, Inc. (K150216) and Skull Mounted Patient Tracker (K141833) Intended Use / Indications for Use The Fiagon Navigation System is intended as… | 2015 |
| * | K141833 | Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer…Summary page 4…y Predicate) • StealthStation System with Synergy Cranial Software, Medtronic Navigation, Inc. (K150216) and Skull Mounted Patient Tracker (K141833) Intended Use / Indications for Use The Fiagon Navigation System is intended as an aid for locating anatomical structures i… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · Direct predicate · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 7 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All HAW devicesHAW Neurological 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 · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Fiagon Navigation System is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but…
Read the full statement (125 words)
The Fiagon Navigation System is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection)
- Skull Base Procedures
- Cranial Biopsies
- General Catheter Shunt Placement
- Pediatric Catheter Shunt Placement
The user should consult the "Bench Accuracy" section of the User Manual to assess whether the accuracy of the system is suitable for their needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163209: Fiagon Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163209
Report an extraction error
Are you the manufacturer?
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