510(k) Report

510(k) · Cleared

Cleared

Stryker Navigation System - Ent Module

K002732510(k) TraditionalCleared Oct 2, 200031-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 Corp. · HAW Neurological Stereotaxic Instrument

Cleared on Oct 2, 2000 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 54 devices in its family, counting itself, has a Class I recall. 53 later devices descend from it.

Decided
Oct 2, 2000
Review
31 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
0

53 later devices descend from it, 3 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2014: 2 descendants cleared2013: 2 descendants cleared2006: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2016: 5 descendants cleared, 1 with a Class I recall12018: 2 descendants cleared2017: 3 descendants cleared2023: 6 descendants cleared2020: 1 descendant cleared2019: 3 descendants cleared2022: 3 descendants cleared2024: 9 descendants cleared2021: 1 descendant cleared2025: 3 descendants cleared2026: 8 descendants cleared200020052010201520202025
  1. This deviceK002732 Stryker Navigation System - Ent ModuleStryker Corp. · 2000
  2. Descendant · cites it directly · 50 of its ownK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
  3. Descendant · 2 generations on · 26 of its ownK131214 Cranial Map NeuroStryker Corporate · 2013
  4. Descendant · 3 generations on · 22 of its ownK141941 Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D…Stryker Corporate · 2014
  5. Descendant · cites it directly · 22 of its ownK130874 Stryker NAV3I PlatformStryker Corporate · 2013
  6. Descendant · cites it directly · 20 of its ownK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 12013: 22014: 22015: 22016: 52017: 32018: 22019: 32020: 12021: 12022: 32023: 62024: 92025: 32026: 8
2006high 9 (2024) · low 0 (2007)2026

Class I recalls in this family

  • K153281 BrightMatter Guide with Surface Trace Registration3 generations on · 2016

Most influential descendants

Showing 5 of 53 · See all
  • K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · cites it directly50descendants
  • K131214Cranial Map NeuroStryker Corporate · 2013 · 2 generations on26descendants
  • K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate · 2014 · 3 generations on22descendants
  • K130874Stryker NAV3I PlatformStryker Corporate · 2013 · cites it directly22descendants
  • K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate · 2014 · cites it directly20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002732Stryker Navigation System - Ent ModuleStryker Corp.2000—
+1K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments200619
+2K131214Cranial Map NeuroStryker Corporate2013—
+3K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap…Stryker Corporate2014—
+1K130874Stryker NAV3I PlatformStryker Corporate2013—
+1K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70…Stryker Corporate20141

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201010
201320
201420
201520
201651
201730
201820
201930
202010
202110
202230
202360
202490
202530
202680
FIG. 1 — Lineage of K002732, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments200650
K130874Stryker NAV3I PlatformStryker Corporate201322
K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate201420

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K062640 (Stryker Instruments, 2006) has gone furthest, with 50 descendants of its own.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

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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
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https://510kreport.com/device/K002732 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002732: Stryker Navigation System - Ent Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002732

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026