510(k) · Cleared
Recalled · 2008Stryker Navigation System-Knee Module
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 Jun 2, 2003 after a 301-day review. The FDA summary names its predicate without a number. 49 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 2, 2003
- Review
- 301 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 7
- Predicates
- 0
49 later devices descend from it, 3 citing it directly.
- This deviceK022579 Stryker Navigation System-Knee ModuleStryker Leibinger · 2003
- Descendant · cites it directly · 22 of its ownK141941 Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D…Stryker Corporate · 2014
- Descendant · cites it directly · 20 of its ownK100742 Exactech GPSBlue Ortho · 2010
- Descendant · 2 generations on · 19 of its ownK152764 Exactech GPSBlue Ortho · 2016 · Recalled
- Descendant · cites it directly · 17 of its ownK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- Descendant · 2 generations on · 16 of its ownK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate · 2014 · cites it directly22descendants
- K100742Exactech GPSBlue Ortho · 2010 · cites it directly20descendants
- K152764Exactech GPSBlue Ortho · 2016 · 2 generations on19descendants
- K153240Styrker OrthoMap Express Knee SystemStryker Corporate · 2016 · cites it directly17descendants
- K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022579 | Stryker Navigation System-Knee Module | Stryker Leibinger | 2003 | — |
| +1 | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap… | Stryker Corporate | 2014 | — |
| +1 | K100742 | Exactech GPS | Blue Ortho | 2010 | — |
| +2 | K152764 | Exactech GPS | Blue Ortho | 2016 | 1 |
| +1 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| +2 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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 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? (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 |
|---|---|---|---|
| * | — | Image guided surgery systems marketed by Stryker, Medtronic, Brainlab, and Aesculap Named without a submission number |
What descends from it? (49)
See all 493 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2008 | Not classified | Z-2288-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2294-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2291-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2289-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2292-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2293-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2290-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141941 (Stryker Corporate, 2014) has gone furthest, with 22 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 - Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022579: Stryker Navigation System-Knee Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022579
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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