510(k) · Cleared
Recalled · Class II · 2020Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System
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 Jul 25, 2014 as substantially equivalent to K050438 (Medtronic Surgical Navigation Technologies, 2005) after a 255-day review. Its family tree reaches back 1 generation to 2005. 3 of the 174 devices in its family, counting itself, have a Class I recall. 172 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2014
- Review
- 255 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050438 (2005). 172 later devices descend from it, 9 citing it directly. 3 of the 174 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- This deviceK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014
- Descendant · cites it directly · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- Descendant · cites it directly · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 39 of its ownK162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
Showing 5 of 172 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 172 · See all- K151511ROSA SpineMedtech S.A · 2016 · cites it directly109descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · cites it directly69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 2 generations on42descendants
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · cites it directly39descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| 0 (this device) | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | — |
| +1 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| +1 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +2 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +1 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017 | Class I |
| +2 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 1 |
| 2018 | 3 | 0 |
| 2019 | 13 | 0 |
| 2020 | 5 | 0 |
| 2021 | 10 | 2 |
| 2022 | 15 | 0 |
| 2023 | 26 | 0 |
| 2024 | 30 | 0 |
| 2025 | 32 | 0 |
| 2026 | 33 | 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.
3 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 |
|---|---|---|---|
| * | K050438 | Stealthstation System UpdateSummary page 2…or digitized landmarks of the anatomy. IX. Identification of Legally Marketing Devices (Predicate Devices) a StealthStation® System Update (K050438) X. Comparison of the Technological Characteristics: The subject of this 510(k) is the StealthStation® System w… | 2005 |
What descends from it? (172)
See all 1729 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151511 | ROSA Spine | 2016 | 109 |
| K171651 | Excelsius GPS | 2017 | 69 |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software Class I | 2017 | 39 |
| K162375 | Envision 3D: Image Guidance System | 2016 | 21 |
| K180352 | 7D Surgical System | 2018 | 8 |
| K180523 | INTAI Surgery Navigation System | 2019 | 7 |
| K181041 | 7D Surgical System Cranial Application | 2018 | 6 |
| K213720 | Vital Navigation System | 2022 | 0 |
| K190556 | Zimmer Biomet Universal Navigation System | 2019 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2020 | Class II | Z-2707-2020 | Nonconforming Material/Component | There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or… |
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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® 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, such as the skull, a long bone, or vertebra, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133444
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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