510(k) · Cleared
Recalled · Class I · 2023Synergy Cranial
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 Jun 11, 2015 as substantially equivalent to K050438 (Medtronic Surgical Navigation Technologies, 2005) after a 132-day review. Its family tree reaches back 1 generation to 2005. 7 of the 151 devices in its family, counting itself, have a Class I recall. 149 later devices descend from it. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Jun 11, 2015
- Review
- 132 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 3 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050438 (2005). 149 later devices descend from it, 5 citing it directly. 7 of the 151 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 deviceK150216 Synergy CranialMedtronic Navigation, Inc. · 2015
- Descendant · cites it directly · 144 of its ownK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 126 of its ownK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 39 of its ownK162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 31 of its ownK190929 xvision Spine system (XVS)Augmedics, Ltd. · 2019
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190672 StealthStation Synergy Cranial S7 Software…cites it directly · 2019
- K153660 StealthStation System with Cranial Softwarecites it directly · 2016
- K162309 StealthStation S8 System Platforms and…2 generations on · 2017
- K221087 Synergy Cranial v2.2.9, StealthStation Cranial…2 generations on · 2022
Most influential descendants
Showing 5 of 149 · See all- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · cites it directly144descendants
- K170011StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017 · 2 generations on126descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 2 generations on39descendants
- K190929xvision Spine system (XVS)Augmedics, Ltd. · 2019 · 3 generations on31descendants
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) | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | — |
| +1 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| +2 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| +3 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +2 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017 | Class I |
| +3 | K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 1 |
| 2017 | 4 | 1 |
| 2018 | 2 | 0 |
| 2019 | 3 | 1 |
| 2020 | 8 | 0 |
| 2021 | 11 | 2 |
| 2022 | 13 | 1 |
| 2023 | 20 | 0 |
| 2024 | 26 | 0 |
| 2025 | 30 | 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? (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 5…StealthStation System Update - K050438 Intended Use The StealthStation® System, with Synergy® The StealthStation® System is intended as an… | 2005 |
What descends from it? (149)
See all 1495 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153660 | StealthStation System with Cranial Software Class I | 2016 | 144 |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Class I | 2019 | 3 |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | 2024 | 1 |
| K151156 | Fiagon Navigation System | 2016 | 1 |
| K163209 | Fiagon Navigation 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… |
| Nov 11, 2021 | Class I | Z-0383-2022 | Software design | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may… |
| 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.
- 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
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 2 generations on · ◆ in the 2017 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 5 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?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Synergy® Cranial software, is intended as an aid for precisely 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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150216: Synergy Cranial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150216
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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