510(k) · Cleared
ClearedSpinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D 3.0-Enable, Spinemap 3D 3.0-Sales D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporate · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 31, 2014 as substantially equivalent to K012380 (Stryker Leibinger, 2001) and 2 other predicates after a 106-day review. Its family tree reaches back 3 generations to 2000. 22 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K993239 (2000). 7 ancestors in all. 22 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 2 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 1 generation backK131214 Cranial Map NeuroStryker Corporate · 2013
- This deviceK141941 Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D…Stryker Corporate · 2014
- Descendant · cites it directly · 12 of its ownK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017
- Descendant · 2 generations on · 10 of its ownK220593 Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022
- Descendant · 2 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
- Descendant · 2 generations on · 7 of its ownK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · cites it directly · 7 of its ownK221028 SURGIVISIO DeviceEcential Robotics · 2022
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation · 2017 · cites it directly12descendants
- K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022 · 2 generations on10descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 2 generations on8descendants
- K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on7descendants
- K221028SURGIVISIO DeviceEcential Robotics · 2022 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −2 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −1 | K131214 | Cranial Map Neuro | Stryker Corporate | 2013 | — |
| 0 (this device) | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap… | Stryker Corporate | 2014 | — |
| +1 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application… | Stryker Corporation | 2017 | — |
| +2 | K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| +2 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| +2 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +1 | K221028 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 6…sk™ Tracker, has the same intended use and substantially equivalent technological characteristics as the predicate devices shown in the following table: 510(k) Number K012380 K131214 K022579 Product Code HAW HAW HAW… | 2001 |
| * | K131214 | Cranial Map NeuroSummary page 6…ded use and substantially equivalent technological characteristics as the predicate devices shown in the following table: 510(k) Number K012380 K131214 K022579 Product Code HAW HAW HAW Trade Name Stryker Naviga… | 2013 |
| * | K022579 | Stryker Navigation System-Knee ModuleSummary page 6…ly equivalent technological characteristics as the predicate devices shown in the following table: 510(k) Number K012380 K131214 K022579 Product Code HAW HAW HAW Trade Name Stryker Navigation Stryke… | 2003 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K172034 (Stryker Corporation, 2017) has gone furthest, with 12 descendants of its own.
- 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. 2014, 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 Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, 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 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.…
Read the full statement (160 words)
The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, 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 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 SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:
• Pedicle screw placement
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient’s skin dorsal to the spine.
• In combination with intraoperative imaging devices, it enables automatic 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/K141941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D 3.0-Enable, Spinemap 3D 3.0-Sales D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141941
Report an extraction error
Are you the manufacturer?
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