510(k) · Cleared
Recalled · 2010Stryker Navigation System - Cranial Module, Model 6000-650-000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · HAW Neurological Stereotaxic Instrument
Cleared on Dec 14, 2006 as substantially equivalent to K993239 (Stryker Corp., 2000) and 2 other predicates after a 99-day review. Its family tree reaches back 1 generation to 2000. 1 of the 54 devices in its family, counting itself, has a Class I recall. 50 later devices descend from it. It has been recalled 19 times.
- Decided
- Dec 14, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 19
- Predicates
- 3
Its longest line of descent runs back 1 generation to K993239 (2000). 3 ancestors in all. 50 later devices descend from it, 5 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- This deviceK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006
- Descendant · cites it directly · 26 of its ownK131214 Cranial Map NeuroStryker Corporate · 2013
- Descendant · 2 generations on · 22 of its ownK141941 Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D…Stryker Corporate · 2014
- Descendant · cites it directly · 20 of its ownK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
- Descendant · 2 generations on · 17 of its ownK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- Descendant · 3 generations on · 16 of its ownK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153281 BrightMatter Guide with Surface Trace Registration2 generations on · 2016
Most influential descendants
Showing 5 of 50 · See all- K131214Cranial Map NeuroStryker Corporate · 2013 · cites it directly26descendants
- K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate · 2014 · 2 generations on22descendants
- K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate · 2014 · cites it directly20descendants
- K153240Styrker OrthoMap Express Knee SystemStryker Corporate · 2016 · 2 generations on17descendants
- K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| 0 (this device) | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | — |
| +1 | K131214 | Cranial Map Neuro | Stryker Corporate | 2013 | — |
| +2 | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap… | Stryker Corporate | 2014 | — |
| +1 | K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70… | Stryker Corporate | 2014 | 1 |
| +2 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| +3 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 1 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 3 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXSummary page 1…gation System - Cranial Module Common Name: Navigation System Classification Name: Stereotaxic Instruments Equivalent to: K993239 Stryker Navigation - Neuro Module K002732 Stryker Navigation - ENT Module… | 2000 |
| * | K002732 | Stryker Navigation System - Ent ModuleSummary page 1…System Classification Name: Stereotaxic Instruments Equivalent to: K993239 Stryker Navigation - Neuro Module K002732 Stryker Navigation - ENT Module K050438 Medtronic StealthStation System Device Description:… | 2000 |
| * | K050438 | Stealthstation System UpdateSummary page 1…alent to: K993239 Stryker Navigation - Neuro Module K002732 Stryker Navigation - ENT Module K050438 Medtronic StealthStation System Device Description: Stryker Navigation System - Cranial Module is part of the product… | 2005 |
What descends from it? (50)
See all 505 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131214 | Cranial Map Neuro | 2013 | 26 |
| K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)… | 2014 | 20 |
| K142024 | Brightmatter Navigation System | 2015 | 12 |
| K083009 | Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000 | 2009 | 1 |
| K093206 | Orthomap 3D 1.1 Module | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2010 | Not classified | Z-1419-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1410-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1418-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1405-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1404-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1407-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1417-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1409-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1408-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1406-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1412-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1411-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1415-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1414-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1416-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1413-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1402-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1403-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
| Nov 10, 2010 | Not classified | Z-1420-2011 | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate… |
The 5 latest of 19 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 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
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.
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 system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures: ENT Procedures * Endoscopic Sinus Surgery (ESS) * Intranasal procedures * Ear implant procedures Neuro Procedures * Cranial biopsies * Puncture of abscesses * Craniotomies * Craniectomies * Resection of tumors and other lesions * Removal of foreign objects * Skull base…
Read the full statement (123 words)
The system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures:
ENT Procedures
* Endoscopic Sinus Surgery (ESS)
* Intranasal procedures
* Ear implant procedures
Neuro Procedures
* Cranial biopsies
* Puncture of abscesses
* Craniotomies
* Craniectomies
* Resection of tumors and other lesions
* Removal of foreign objects
* Skull base procedures
* Transnasal neurosurgical procedures
* Transphenoidal pituitary surgery
* Shunt placement, including pediatric shunt placement
* Placement of electrodes for recording, stimulation and lesion generation
* Craniofacial procedures
* Skull reconstruction procedures
* Orbital cavity reconstruction procedures
Contraindications
* Surgical situation where increasing surgical time may be detrimental to the patient.
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/K062640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062640
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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