510(k) · Cleared
Recalled · 2009Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 18, 2000 after a 113-day review. The FDA summary names its predicate without a number. 1 of the 83 devices in its family, counting itself, has a Class I recall. 82 later devices descend from it. It has been recalled 6 times.
- Decided
- Jan 18, 2000
- Review
- 113 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 6
- Predicates
- 0
82 later devices descend from it, 3 citing it directly. 1 of the 83 devices in this family, counting this one, has a Class I recall.
- This deviceK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000
- Descendant · cites it directly · 50 of its ownK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- Descendant · cites it directly · 29 of its ownK050615 Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Stryker Instruments · 2005
- Descendant · 2 generations on · 26 of its ownK131214 Cranial Map NeuroStryker Corporate · 2013
- Descendant · 3 generations on · 22 of its ownK141941 Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D…Stryker Corporate · 2014
- Descendant · 2 generations on · 20 of its ownK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153281 BrightMatter Guide with Surface Trace Registration3 generations on · 2016
Most influential descendants
Showing 5 of 82 · See all- K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · cites it directly50descendants
- K050615Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Stryker Instruments · 2005 · cites it directly29descendants
- K131214Cranial Map NeuroStryker Corporate · 2013 · 2 generations on26descendants
- K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate · 2014 · 3 generations on22descendants
- K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate · 2014 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | — |
| +1 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| +1 | K050615 | Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000 | Stryker Instruments | 2005 | — |
| +2 | K131214 | Cranial Map Neuro | Stryker Corporate | 2013 | — |
| +3 | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap… | Stryker Corporate | 2014 | — |
| +2 | K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70… | Stryker Corporate | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 1 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 12 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | — | Sofamor Danek image guided surgery system Named without a submission number | |
| * | — | Zeiss image guided surgery system Named without a submission number | |
| * | — | BrainLab image guided surgery system Named without a submission number |
What descends from it? (82)
See all 823 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2009 | Not classified | Z-0122-2010 | Software design | Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very… |
| Oct 26, 2009 | Not classified | Z-0123-2010 | Software design | Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very… |
| Sep 8, 2006 | Not classified | Z-0005-2007 | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. |
| Sep 8, 2006 | Not classified | Z-0006-2007 | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. |
| Sep 8, 2006 | Not classified | Z-0007-2007 | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. |
| Sep 8, 2006 | Not classified | Z-0008-2007 | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. |
The 5 latest of 6 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.
- K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K062640 (Stryker Instruments, 2006) has gone furthest, with 50 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?
The Stryker Navigation System — Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.
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/K993239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993239: Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993239
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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