510(k) · Cleared
ClearedStryker OrthoMap Precision Knee system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 12, 2016 as substantially equivalent to K153240 (Stryker Corporate, 2016) after a 51-day review. Its family tree reaches back 4 generations to 2000. 16 later devices descend from it.
- Decided
- Oct 12, 2016
- Review
- 51 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993239 (2000). 9 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- 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 backK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
- 1 generation backK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- This deviceK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
- Descendant · cites it directly · 12 of its ownK172034 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 · 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 · 3 generations on · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · 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 · cites it directly10descendants
- 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
- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · 3 generations on4descendants
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 | K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70… | Stryker Corporate | 2014 | 1 |
| −1 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| 0 (this device) | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
| +1 | 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 | — |
| +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 | — |
| +3 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K153240 | Styrker OrthoMap Express Knee SystemSummary page 4…Instrument Panel: Orthopedic Product Code: OLO - Orthopedic Stereotaxic Instrument Predicate Device: K153240 – Stryker OrthoMap Express Knee system Indication for Use:… | 2016 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock… | 2017 | 12 |
| K220593 | Spine Guidance Software, Stryker Q Guidance System | 2022 | 10 |
| K213380 | 360CAS | 2022 | 2 |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho… | 2023 | 1 |
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 16 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K172034 (Stryker Corporation, 2017) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K153240.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 OrthoMap Precision Knee system, which is comprised of the OrthoMap Precision Knee 5.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery.
The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
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/K162341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162341: Stryker OrthoMap Precision Knee system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162341
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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