510(k) · Cleared
ClearedNavSuite3 Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co. KG - Navigation · HAW Neurological Stereotaxic Instrument
Cleared on Jul 8, 2015 as substantially equivalent to K130874 (Stryker Corporate, 2013) after a 152-day review. Its family tree reaches back 2 generations to 2000. 18 later devices descend from it.
- Decided
- Jul 8, 2015
- Review
- 152 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002732 (2000). 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002732 Stryker Navigation System - Ent ModuleStryker Corp. · 2000
- 1 generation backK130874 Stryker NAV3I PlatformStryker Corporate · 2013
- This deviceK150301 NavSuite3 KitStryker Leibinger GmbH & Co. KG - Navigation · 2015
- 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
- Descendant · 3 generations on · 12 of its ownK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017
- Descendant · 3 generations on · 10 of its ownK220593 Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022
- Descendant · 4 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K153240Styrker OrthoMap Express Knee SystemStryker Corporate · 2016 · cites it directly17descendants
- K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016 · 2 generations on16descendants
- K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation · 2017 · 3 generations on12descendants
- K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022 · 3 generations on10descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002732 | Stryker Navigation System - Ent Module | Stryker Corp. | 2000 | — |
| −1 | K130874 | Stryker NAV3I Platform | Stryker Corporate | 2013 | — |
| 0 (this device) | K150301 | NavSuite3 Kit | Stryker Leibinger GmbH & Co. KG - Navigation | 2015 | — |
| +1 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| +2 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
| +3 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application… | Stryker Corporation | 2017 | — |
| +3 | K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| +4 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 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 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 |
|---|---|---|---|
| * | K130874 | Stryker NAV3I PlatformSummary page 5…ogical Stereotaxic Instrument Secondary Product Code: OLO – Orthopedic Stereotaxic Instrument Predicate Device: Stryker NAV3i Platform (K130874) Indication for Use: The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, di… | 2013 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153240 | Styrker OrthoMap Express Knee System | 2016 | 17 |
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 15 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153240 (Stryker Corporate, 2016) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K130874.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic…
Read the full statement (135 words)
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques.
The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150301: NavSuite3 Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150301
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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