510(k) · Cleared
Recalled · Class I · 2023StealthStation System with Cranial Software
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 Sep 14, 2016 as substantially equivalent to K150216 (Medtronic Navigation, Inc., 2015) and 1 other predicate after a 268-day review. Its family tree reaches back 2 generations to 2005. 7 of the 148 devices in its family, counting itself, have a Class I recall. 144 later devices descend from it. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Sep 14, 2016
- Review
- 268 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 3 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K050438 (2005). 3 ancestors in all, the oldest K992927 (1999). 144 later devices descend from it, 4 citing it directly. 7 of the 148 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 1 generation backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- This deviceK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016
- Descendant · cites it directly · 126 of its ownK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- 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 · 31 of its ownK190929 xvision Spine system (XVS)Augmedics, Ltd. · 2019
- Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
Showing 5 of 144 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 144 · See all- K170011StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017 · cites it directly126descendants
- 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
- K190929xvision Spine system (XVS)Augmedics, Ltd. · 2019 · 2 generations on31descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −1 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| 0 (this device) | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | — |
| +1 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| +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 | K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019 | — |
| +3 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 1 |
| 2018 | 2 | 0 |
| 2019 | 3 | 1 |
| 2020 | 8 | 0 |
| 2021 | 11 | 2 |
| 2022 | 13 | 1 |
| 2023 | 20 | 0 |
| 2024 | 25 | 0 |
| 2025 | 29 | 0 |
| 2026 | 30 | 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.
7 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? (2)
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 |
|---|---|---|---|
| * | K150216 | Synergy CranialSummary page 5….0 Software) Intended Use The StealthStation® System, with Synergy® Cranial v2.2.7 Software - StealthStation® Cranial software is K150216 designed as an aid for locating The StealthStation® System, with anatomical struc… | 2015 |
| * | K992927 | Stealthstation Treatment Guidance PlatformSummary page 7…edicate: Natrex™ Device for StealthStation System K992927 Stereotactic Localizer Registration Planning Plan Entry and… | 1999 |
What descends from it? (144)
See all 1444 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170011 | StealthStation S8 Spine Software v1.0.0 | 2017 | 126 |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software Class I | 2017 | 39 |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Class I | 2019 | 3 |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | 2017 | 0 |
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2023 | Class I | Z-1666-2023 | Software design | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where… |
| Aug 9, 2019 | Class I | Z-1995-2020 | Software design | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging… |
| Sep 26, 2018 | Class I | Z-0552-2019 | Device Design | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue. |
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 · ◆ on the line of descent in FIG. 13 Class I recalls
- 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
- K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Medtronic Navigation, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- 3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170011 (Medtronic Navigation, 2017) has gone furthest, with 126 descendants of its own.
- 4 other devices also cite its predicate K150216.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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, with StealthStation Cranial Software, is intended to aid in locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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…
Read the full statement (138 words)
The StealthStation System, with StealthStation Cranial Software, is intended to aid in locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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):
- Cranial Biopsies
- Deep Brain Stimulation (DBS) Lead Placement
- Depth Electrode Placement
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement
The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153660: StealthStation System with Cranial Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153660
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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