510(k) · Cleared
ClearedStryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
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 Oct 18, 2017 as substantially equivalent to K141941 (Stryker Corporate, 2014) and 2 other predicates after a 105-day review. Its family tree reaches back 5 generations to 2000. 12 later devices descend from it.
- Decided
- Oct 18, 2017
- Review
- 105 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K993239 (2000). 13 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 4 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 3 generations backK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
- 2 generations backK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- 1 generation backK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
- This deviceK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017
- Descendant · cites it directly · 10 of its ownK220593 Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022
- Descendant · cites it directly · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
- Descendant · cites it directly · 7 of its ownK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 2 generations on · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 3 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022 · cites it directly10descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · cites it directly8descendants
- K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG · 2024 · cites it directly7descendants
- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on4descendants
- K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −4 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −3 | 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 | — |
| −1 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
| 0 (this device) | K172034 | Stryker Spine Navigation System with SpineMap 3D software application… | Stryker Corporation | 2017 | — |
| +1 | K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| +1 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| +1 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +2 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +3 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | — |
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 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Summary page 10…tryker SpineMap Stryker Leibinger SpineMap 3D 3D Navigation K141941 OLO GmbH & Co. KG Software… | 2014 |
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 10…Application nGenius Spine Percutaneous Spine Stryker Leibinger K012380 HAW Clamp Clamp GmbH & Co. KG… | 2001 |
| * | K162341 | Stryker OrthoMap Precision Knee systemSummary page 10…GmbH & Co. KG Stryker Leibinger OrthoLock OrthoLock K162341 OLO GmbH & Co. KG Navigated Dr… | 2016 |
| * | — | OASYS Adjustable Drill Guide Named without a submission number | |
| * | — | OASYS Drill Bits Named without a submission number | |
| * | — | Xia CT Drill Bit Named without a submission number | |
| * | — | Xia 4.5 Refresh Locking Knob Named without a submission number |
What descends from it? (12)
See all 123 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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K220593 (Stryker Leibinger GmbH & Co KG, 2022) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K141941.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Navigation System, when used with the SpineMap® 3D 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 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 such as the pelvis or…
Read the full statement (648 words)
The Stryker Navigation System, when used with the SpineMap® 3D 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 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 such as the pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
- Screw Placement in the spine, ilium, or pelvis
The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.
The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.
The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, 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 Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.
The Navigated Drill Guide Set may be used as part of the Stryker Spine 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 Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Awl Taps may be used as part of the Stryker Spine 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 Navigated Xia 3 Awl Taps are intended for use with the Rotational Navigation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.
The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Serrato Taps may be used as part of the Stryker Spine 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 Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172034: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172034
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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