510(k) · Cleared
Recalled · Class II · 2017Stealthstation System Update
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Surgical Navigation Technologies · HAW Neurological Stereotaxic Instrument
Cleared on Jun 2, 2005 after a 100-day review. The FDA summary names its predicate without a number. 14 of the 945 devices in its family, counting itself, have a Class I recall. 944 later devices descend from it. It has been recalled 11 times.
- Decided
- Jun 2, 2005
- Review
- 100 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 11
- Predicates
- 0
944 later devices descend from it, 23 citing it directly. 14 of the 945 devices in this family, counting this one, have a Class I recall.
- This deviceK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005
- Descendant · cites it directly · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 246 of its ownK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 242 of its ownK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 944 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 944 · See all- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · cites it directly404descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on396descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. · 2013 · 2 generations on246descendants
- K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on242descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | — |
| +1 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +2 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +2 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| +3 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 17 | 0 |
| 2015 | 30 | 2 |
| 2016 | 33 | 2 |
| 2017 | 55 | 1 |
| 2018 | 46 | 1 |
| 2019 | 64 | 2 |
| 2020 | 60 | 1 |
| 2021 | 77 | 2 |
| 2022 | 92 | 1 |
| 2023 | 115 | 0 |
| 2024 | 107 | 0 |
| 2025 | 117 | 2 |
| 2026 | 96 | 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.
14 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 |
|---|---|---|---|
| * | — | StealthStation System Named without a submission number |
What descends from it? (944)
See all 94423 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | 2013 | 404 |
| K053610 | Abaris | 2006 | 278 |
| K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 | 172 |
| K150216 | Synergy Cranial Class I | 2015 | 149 |
| K060556 | Brigit Surgical Device | 2006 | 128 |
| K170011 | StealthStation S8 Spine Software v1.0.0 | 2017 | 126 |
| K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | 2006 | 50 |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software Class I | 2017 | 39 |
| K111811 | Bendini (TM) Spinal Rod Bending System | 2011 | 36 |
| K112718 | Nuvasive NVM5 System | 2012 | 35 |
Has anything in its family been recalled? (14 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2017 | Class II | Z-2746-2017 | Software in the Use Environment | Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with… |
| Jul 18, 2016 | Class II | Z-2318-2016 | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. |
| Jul 18, 2016 | Class II | Z-2313-2016 | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. |
| Sep 14, 2015 | Class II | Z-2824-2015 | Labeling design | Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. |
| Nov 13, 2012 | Class II | Z-0441-2013 | Process control | Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up. |
| Jun 2, 2011 | Not classified | Z-2781-2011 | Software design | Software allows incorrect patient or patient history to be displayed. |
| Dec 22, 2010 | Not classified | Z-1558-2011 | Component design/selection | Position Sensor Unit may generate tracking errors or may stop tracking immediately. |
| Dec 15, 2010 | Not classified | Z-1042-2011 | Component design/selection | Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery. |
| Nov 5, 2010 | Not classified | Z-0715-2011 | Component design/selection | Electronic surgical navigation aid may lose tracking ability or stop working. |
| Sep 24, 2010 | Not classified | Z-0145-2011 | Other | Drill guide handle may detach unintentionally during use. |
| Jun 14, 2010 | Not classified | Z-2029-2010 | Device Design | Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock. |
The 5 latest of 11 recalls; the web page lists all.
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 · Cites it directly · ◆ in the 2015 descendants bar of 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 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
- K151359ROSA BrainMedtech S.A · 2015 · 4 generations on · ◆ in the 2015 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
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- Of its descendants, K124004 (Medtronic Navigation, Inc., 2013) has gone furthest, with 404 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This submission does not change the indications for use for the StealthStation System. 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…
Read the full statement (242 words)
This submission does not change the indications for use for the StealthStation System.
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.
For the optical-based and EM-based system, example procedures include, but are not limited to:
Cranial Procedures:
Cranial Biopsies
Tumor Resections
Craniotomies/ Craniectomies
Skull Base procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF Leak Repair
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
Spinal Procedures
Spinal Implant Procedures, such as Pedicle Screw Placement
ENT Procedures:
Transphenoidal Procedures
Intranasal Procedures
Orbital Nerve Decompression Procedures
Optic Nerve Decompression Procedures
Polyposis Procedures
Endoscopic Dacryocystorhinostomy
Encephalocele Procedures
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations. Turbinate Resections, and Frontal Sinusotomies
Orthopaedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Additional example procedures for the optical-based system include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Minimally Invasive Orthopaedic Procedures
Pediatric Orthopaedics
Total Hip Replacement (Primary and Revision)
Periacetabular Osteotomies
Tumor Resection and Bone/Joint Reconstruction
Femoral Revision
Placement of Iliosacral Screws
Stabilization and Repair of Pelvic Fractures (Including but not limited to Acetabular Fractures)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050438: Stealthstation System Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050438
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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