510(k) · Cleared
Recalled · Class I · 2023StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
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 31, 2019 as substantially equivalent to K150216 (Medtronic Navigation, Inc., 2015) and 1 other predicate after a 138-day review. Its family tree reaches back 3 generations to 2005. 4 of the 8 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jul 31, 2019
- Review
- 138 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K050438 (2005). 4 ancestors in all, the oldest K992927 (1999). 3 later devices descend from it, 1 citing it directly. 4 of the 8 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 deviceK190672 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation…Medtronic Navigation, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK221087 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK231976 StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK243657 ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022 · cites it directly2descendants
- K231976StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc. · 2023 · 2 generations on1descendant
- K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025 · 3 generations on0descendants
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) | K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial… | Medtronic Navigation, Inc. | 2019 | — |
| +1 | K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Medtronic Navigation, Inc. | 2022 | Class I |
| +2 | K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023 | — |
| +3 | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025 | — |
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 |
|---|---|---|
| 2022 | 1 | 1 |
| 2023 | 1 | 0 |
| 2025 | 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? (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…60) IV. Classification: Class II, Stereotaxic Instrument V. Product Codes: HAW VI. Predicates: Medtronic Navigation, Inc. manufactured software; • K150216, StealthStation System with Synergy Cranial v2.2.7 software • K153660, StealthStation System with StealthStation Cranial… | 2015 |
| * | K153660 | StealthStation System with Cranial SoftwareSummary page 5…des: HAW VI. Predicates: Medtronic Navigation, Inc. manufactured software; • K150216, StealthStation System with Synergy Cranial v2.2.7 software • K153660, StealthStation System with StealthStation Cranial v3.0 Software VII. Product Description The StealthStation® System, w… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Class I | 2022 | 2 |
Has anything in its family been recalled? (4 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… |
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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K221087 (Medtronic Navigation, Inc., 2022) has gone furthest, with 2 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. 2019, 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 Synergy® Cranial software is surgical navigation software that, when used with the StealthStation® System as a planning and intraoperative guidance system, is intended to aid in 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…
Read the full statement (226 words)
The Synergy® Cranial software is surgical navigation software that, when used with the StealthStation® System as a planning and intraoperative guidance system, is intended to aid in 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
The StealthStation® System, with StealthStation® Cranial software, is intended to aid in 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 (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
• Cranial biopsies (including stereotactic)
• 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190672: StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190672
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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