510(k) · Cleared
Recalled · Class II · 2017Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · HAW Neurological Stereotaxic Instrument
Cleared on Dec 3, 2001 after a 130-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 273 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 2001
- Review
- 130 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 0
273 later devices descend from it, 10 citing it directly.
- This deviceK012380 Modification to: Stryker Navigation System, Stryker Fluoroscopy…Stryker Leibinger · 2001
- Descendant · cites it directly · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 273 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 273 · See all- K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · cites it directly238descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual… | Stryker Leibinger | 2001 | — |
| +1 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| +2 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +4 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 9 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 26 | 0 |
| 2023 | 16 | 0 |
| 2024 | 33 | 0 |
| 2025 | 33 | 0 |
| 2026 | 22 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (273)
See all 27310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032117 | Stryker Total Performance (TPS) System | 2003 | 238 |
| K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D… | 2014 | 22 |
| K032303 | Stryker Consolidated Operating Room Equipment (Core) System | 2004 | 14 |
| K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock… | 2017 | 12 |
| K040369 | Stryker Consolidated Operating Room Equipment (Core) System | 2004 | 7 |
| K040300 | Stryker Consolidated Operating Room Equipment (Core) | 2004 | 7 |
| K140868 | Stryker Kwic Needle | 2014 | 1 |
| K083009 | Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000 | 2009 | 1 |
| K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers… | 2019 | 0 |
| K143597 | Navigated XIA 4.5 Polyaxial Screwdriver | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2017 | Class II | Z-1216-2018 | Software Manufacturing/Software Deployment | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System because the settings on the machine were… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032117 (Stryker Instruments, 2003) has gone furthest, with 238 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 is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. The Stryker Navigation System- Spine & Fluoroscopy Module supports, but…
Read the full statement (126 words)
The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images.
The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures:
Pedicle Screw Placement
Navigation
Precisely pasitioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones.
This submission is not intended for total joint replacement procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012380
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026