510(k) · Cleared
ClearedStealth AXiS Cranial clinical application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Mar 26, 2026 as substantially equivalent to K212397 (Medtronic Navigation, 2021) after a 177-day review. Its family tree reaches back 7 generations to 2005. 4 of the 10 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 26, 2026
- Review
- 177 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K050438 (2005). 9 ancestors in all, the oldest K992927 (1999). No later device cites it as a predicate yet. 4 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 6 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 5 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 4 generations backK162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Recalled (Class I)
- 3 generations backK201175 StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc. · 2020
- 2 generations backK203639 StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc. · 2021
- 1 generation backK212397 StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · Recalled (Class I)
- This deviceK253379 Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −6 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −5 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −4 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017 | Class I |
| −3 | K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | — |
| −2 | K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | 2021 | — |
| −1 | K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | 2021 | Class I |
| 0 (this device) | K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2014 | 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.
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 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? (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 |
|---|---|---|---|
| * | K212397 | StealthStation S8 Cranial v2.0Summary page 5…Stealth AXiS Cranial clinical application v1.0 Predicate Device StealthStation S8 Cranial Software v2.0 (K212397, cleared December 22, 2021) Reference Device SureTune4 Software (DEN210003,… | 2021 |
| † | DEN210003 | SureTune4 Software | 2021 |
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.
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K212397.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Stealth AXiS Surgical System, with the Stealth AXiS Cranial clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be…
Read the full statement (118 words)
The Stealth AXiS Surgical System, with the Stealth AXiS Cranial clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
• Tumor resections
• General ventricular catheter placement
• Pediatric ventricular catheter placement
• Depth electrode, lead, and probe placement
• Cranial biopsies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253379: Stealth AXiS Cranial clinical application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253379
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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