510(k) · Cleared
ClearedStryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on Feb 14, 2019 as substantially equivalent to K012380 (Stryker Leibinger, 2001) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Feb 14, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K993239 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 3 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 2 generations backK131214 Cranial Map NeuroStryker Corporate · 2013
- 1 generation backK141941 Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D…Stryker Corporate · 2014
- This deviceK183196 Stryker Navigation System with SpineMap Go Software Application…Stryker Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −3 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −2 | K131214 | Cranial Map Neuro | Stryker Corporate | 2013 | — |
| −1 | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap… | Stryker Corporate | 2014 | — |
| 0 (this device) | K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy… | Stryker Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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.
Planning a device in OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 6…Product Code Stryker Navigation System Stryker Navigation System – Spine with the SpineMap Go and Fluoroscopy System with K012380 HAW Software Application Fluoroscopy 2.3 Software SpineMask Tracker SpineMask Tracker… | 2001 |
| * | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Summary page 6…tem with K012380 HAW Software Application Fluoroscopy 2.3 Software SpineMask Tracker SpineMask Tracker K141941 OLO Fluoroscopy Adapter (Philips Fluoroscopy Adapter (Philips… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 9 other devices also cite its predicate K012380.
How does its category compare?
All OLO devicesOLO Orthopedic 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 · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Fluoroscopy Adapters and Fluoroscopy Trackers are intended to be used as accessories to the Stryker Navigation System. The Fluoroscopy Tracker is connected to the Fluoroscopy Adapter which is attached to the C-arm fluoroscopy system. The Fluoroscopy Tracker transmits signals that are used by the Stryker Navigation System to calculate the spatial relationship between the C-arm and the patient. The Fluoroscopy Adapter and Fluoroscopy Tracker may be…
Read the full statement (289 words)
The Fluoroscopy Adapters and Fluoroscopy Trackers are intended to be used as accessories to the Stryker Navigation System. The Fluoroscopy Tracker is connected to the Fluoroscopy Adapter which is attached to the C-arm fluoroscopy system. The Fluoroscopy Tracker transmits signals that are used by the Stryker Navigation System to calculate the spatial relationship between the C-arm and the patient.
The Fluoroscopy Adapter and Fluoroscopy Tracker may be used as part of the Stryker Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Stryker Navigation System, when used with the SpineMap Go software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system is indicated for any medical condition in which computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the pelvis, skull, or spine can be identified.
The system assists in the positioning of instruments for procedures on the spine and pelvis, including the following procedures:
- Screw Placement in the spine and pelvis
- Needle Placement in the spine and pelvis
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker Spine Navigation Systems. It is placed onto the patient’s skin dorsal to the spine.
• In combination with intraoperative imaging devices, it enables patient registration for open or percutaneous computer assisted surgery.
• When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183196: Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183196
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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