510(k) Report

510(k) · Cleared

Cleared

Stryker NAV3I Platform

K130874510(k) TraditionalCleared Sep 27, 2013182-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Corporate · HAW Neurological Stereotaxic Instrument

Cleared on Sep 27, 2013 as substantially equivalent to K002732 (Stryker Corp., 2000) after a 182-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it.

Decided
Sep 27, 2013
Review
182 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002732 (2000). 22 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2023: 2 descendants cleared2022: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2024: 5 descendants cleared2021: 1 descendant cleared2026: 4 descendants cleared2025: 1 descendant clearedK002732 · Stryker Navigation System - Ent Module · Stryker Corp. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants K002732 · Stryker Navigation System - Ent Module · Stryker Corp. · 20000+5
  1. Root · 1 generation backK002732 Stryker Navigation System - Ent ModuleStryker Corp. · 2000
  2. This deviceK130874 Stryker NAV3I PlatformStryker Corporate · 2013
  3. Descendant · cites it directly · 20 of its ownK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
  4. Descendant · cites it directly · 18 of its ownK150301 NavSuite3 KitStryker Leibinger GmbH & Co. KG - Navigation · 2015
  5. Descendant · cites it directly · 17 of its ownK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
  6. Descendant · 2 generations on · 16 of its ownK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
  7. Descendant · 3 generations on · 12 of its ownK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 22017: 12018: 12020: 12021: 12022: 22023: 22024: 52025: 12026: 4
2014high 5 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 22 · See all
  • K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate · 2014 · cites it directly20descendants
  • K150301NavSuite3 KitStryker Leibinger GmbH & Co. KG - Navigation · 2015 · cites it directly18descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002732Stryker Navigation System - Ent ModuleStryker Corp.2000—
0 (this device)K130874Stryker NAV3I PlatformStryker Corporate2013—
+1K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70…Stryker Corporate20141
+1K150301NavSuite3 KitStryker Leibinger GmbH & Co. KG - Navigation2015—
+1K153240Styrker OrthoMap Express Knee SystemStryker Corporate2016—
+2K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG2016—
+3K172034Stryker Spine Navigation System with SpineMap 3D software application…Stryker Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201620
201710
201810
202010
202110
202220
202320
202450
202510
202640
FIG. 1 — Lineage of K130874, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002732Stryker Navigation System - Ent Module
Summary page 2
…f 8 3. Legally Marketed Predicate Device The legally marketed predicate device is the Cart I Platform (trade name: Stryker Navigation Cart) as cleared in K002732 Stryker Navigation System - ENT Module. 510(k) Number Product Code Trade Name Manufacture! K(0027…
Stryker Corp.2000—

Also cleared against K002732: 2 other devices →

What descends from it? (22)

See all 22

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate201420
K150301NavSuite3 KitStryker Leibinger GmbH & Co. KG - Navigation201518
K153240Styrker OrthoMap Express Knee SystemStryker Corporate201617

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?

  • Its one ancestor has no recall.
  • Of its descendants, K141551 (Stryker Corporate, 2014) has gone furthest, with 20 descendants of its own.
  • 2 other devices also cite its predicate K002732.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HAW

9in 2025

2007: 152008: 122009: 82010: 62011: 42012: 82013: 32014: 52015: 102016: 92017: 72018: 62019: 102020: 52021: 92022: 72023: 142024: 72025: 92026 (partial year): 5
2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007: 107 days median2008: 112 days median2009: 221 days median2010: 138 days median2011: 66 days median2012: 178 days median2013: 172 days median2014: 238 days median2015: 232 days median2016: 175 days median2017: 226 days median2018: 112 days median2019: 147 days median2020: 88 days median2021: 168 days median2022: 128 days median2023: 142 days median2024: 107 days median2025: 163 days median2026 (partial year): 162 days median
2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007: 22008: 102009: 62010: 282011: 52012: 42013: 6, 1 Class I2014: 52015: 32016: 52017: 22018: 2, 2 Class I2019: 4, 1 Class I2020: 12021: 4, 2 Class I2022: 12023: 4, 1 Class I2024: 2, 2 Class I2025: 22026 (partial year): 6
2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007: 492008: 532009: 962010: 2992011: 1,7252012: 9862013: 1,2902014: 1,6062015: 1,7672016: 1,8282017: 3,5052018: 4,4392019: 6,0622020: 3,4802021: 2,8272022: 1,9292023: 2,5102024: 3,7552025: 3,425
2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715107249
2008121121053
20098221696
2010613828299
201146651,725
201281784986
201331726 (1)1,290
2014523851,606
20151023231,767
2016917551,828
2017722623,505
201861122 (2)4,439
2019101474 (1)6,062
202058813,480
202191684 (2)2,827
2022712811,929
2023141424 (1)2,510
202471072 (2)3,755
2025916323,425
202651626—

What is it indicated for?

The NAV3I Platform is a computer workstation that, when used with specific Stryker Navigation surgical 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 NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Indications for use as stated in the FDA summary.

Also cleared against K002732

2 other devices cite the same predicate.

  • K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved…Stryker Corporate · 20141 recall
  • K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 200619 recalls

More from Stryker Corporate

6 FDA decisions under this applicant name. See the company

  • K153240Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
  • K143597Navigated XIA 4.5 Polyaxial ScrewdriverStryker Corporate · 2015
  • K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D 3.0-Enable, Spinemap 3D…Stryker Corporate · 2014
  • K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved…Stryker Corporate · 20141 recall
  • K131214Cranial Map NeuroStryker Corporate · 2013

Recent decisions in HAW

The HAW category page

  • K262214Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)Guangzhou Aimooe Technology Co., Ltd. · 2026
  • K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
  • K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
  • K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026
  • K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026

https://510kreport.com/device/K130874 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130874: Stryker NAV3I Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130874

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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