510(k) · Cleared
Recalled · Class I · 2024StealthStation S8 System Platforms and StealthStation 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 Mar 31, 2017 as substantially equivalent to K153660 (Medtronic Navigation, Inc., 2016) and 2 other predicates after a 226-day review. Its family tree reaches back 3 generations to 2005. 4 of the 45 devices in its family, counting itself, have a Class I recall. 39 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Mar 31, 2017
- Review
- 226 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 3 generations to K050438 (2005). 5 ancestors in all, the oldest K992927 (1999). 39 later devices descend from it, 9 citing it directly. 4 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 2 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 1 generation backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- This deviceK162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017
- Descendant · cites it directly · 16 of its ownK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- Descendant · 2 generations on · 15 of its ownK200935 Mazor XMazor Robotics, Ltd. · 2020
- Descendant · 3 generations on · 14 of its ownK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- Descendant · 4 generations on · 9 of its ownK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · cites it directly · 8 of its ownK201175 StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc. · 2020
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 39 · See all- K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · cites it directly16descendants
- K200935Mazor XMazor Robotics, Ltd. · 2020 · 2 generations on15descendants
- K203005Mazor XMazor Robotics, Ltd. · 2020 · 3 generations on14descendants
- K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021 · 4 generations on9descendants
- K201175StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc. · 2020 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −2 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −1 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| 0 (this device) | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017 | — |
| +1 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| +2 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| +3 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
| +4 | K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +1 | K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 1 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K153660 | StealthStation System with Cranial Software Cleared while this submission was under review Summary page 6…User Manual to assess if the accuracy of the system is suitable for their needs. IX. Identification of Legally Marketed Devices (Predicate Devices): K153660 - Synergy Cranial 3.0 Software K050438 - StealthStation™ System Update K133444 - StealthStation™ System Update X… | 2016 |
| * | K050438 | Stealthstation System UpdateSummary page 6…f the system is suitable for their needs. IX. Identification of Legally Marketed Devices (Predicate Devices): K153660 - Synergy Cranial 3.0 Software K050438 - StealthStation™ System Update K133444 - StealthStation™ System Update X. Comparison of the Technological Characte… | 2005 |
| * | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemSummary page 6…Identification of Legally Marketed Devices (Predicate Devices): K153660 - Synergy Cranial 3.0 Software K050438 - StealthStation™ System Update K133444 - StealthStation™ System Update X. Comparison of the Technological Characteristics: Item Subject Device… | 2014 |
What descends from it? (39)
See all 399 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182077 | Mazor X System (Mazor X Stealth Edition) | 2018 | 16 |
| K201175 | StealthStation Cranial Software v1.3.0 | 2020 | 8 |
| K200047 | ExcelsiusGPS Cranial 1.0 Module | 2020 | 5 |
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | 2022 | 4 |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation System | 2023 | 3 |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | 2024 | 2 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | 2025 | 1 |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and… | 2023 | 1 |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | 2026 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2024 | Class I | Z-1776-2024 | Software design | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. |
| 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… |
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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K182077 (Mazor Robotics, Ltd., 2018) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K153660.
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 StealthStation™ System, with StealthStation™ Cranial software, is intended as an aid for locating anatomical structures in either open or 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…
Read the full statement (204 words)
The StealthStation™ System, with StealthStation™ Cranial software, is intended as an aid for locating anatomical structures in either open or 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
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.
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 or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162309: StealthStation S8 System Platforms and StealthStation 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/K162309
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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