510(k) Report

510(k) · Cleared

Cleared

7D Surgical System Cranial Application

K181041510(k) TraditionalCleared Aug 8, 2018111-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

7D Surgical, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Aug 8, 2018 as substantially equivalent to K162375 (7D Surgical, Inc., 2016) and 2 other predicates after a 111-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.

Decided
Aug 8, 2018
Review
111 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K993239 (2000). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 1 other ancestor2014: 1 other ancestor2005: 1 other ancestor2000: 1 other ancestor2019: 1 descendant cleared2024: 3 descendants cleared2023: 1 descendant cleared2026: 1 descendant clearedReference device: K033621 · Ndi Passive Spheres · Northern Digital, Inc. · 2004 · recalledK993239 · Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX · Stryker Corp. · 2000 · recalledK062640 · Stryker Navigation System - Cranial Module, Model 6000-650-000 · Stryker Instruments · 2006 · recalledK142024 · Brightmatter Navigation System · Synaptive Medical, Inc. · 2015 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K142024 · Brightmatter Navigation System · Synaptive Medical, Inc. · 2015 · recalledK062640 · Stryker Navigation System - Cranial Module, Model 6000-650-000 · Stryker Instruments · 2006 · recalledK993239 · Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX · Stryker Corp. · 2000 · recalled0+5
  1. Root · 3 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
  2. 2 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
  3. 1 generation backK142024 Brightmatter Navigation SystemSynaptive Medical, Inc. · 2015 · Recalled
  4. This deviceK181041 7D Surgical System Cranial Application7D Surgical, Inc. · 2018
  5. Descendant · cites it directly · 5 of its ownK192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement…7D Surgical, Inc. · 2019
  6. Descendant · 2 generations on · 3 of its ownK230661 Zeta Cranial Navigation SystemZeta Surgical · 2023
  7. Descendant · 3 generations on · 2 of its ownK233903 Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024
  8. Descendant · 4 generations on · 1 of its ownK242351 Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024
  9. Descendant · 5 generations on · 0 of its ownK253663 Zeta Navigation SystemZeta Surgical, Inc. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019: 12023: 12024: 32026: 1
2019high 3 (2024) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 2019 · cites it directly5descendants
  • K230661Zeta Cranial Navigation SystemZeta Surgical · 2023 · 2 generations on3descendants
  • K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024 · 3 generations on2descendants
  • K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024 · 4 generations on1descendant
  • K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993239Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp.20006
−2K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments200619
−1K142024Brightmatter Navigation SystemSynaptive Medical, Inc.20151
0 (this device)K1810417D Surgical System Cranial Application7D Surgical, Inc.2018—
+1K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.2019—
+2K230661Zeta Cranial Navigation SystemZeta Surgical2023—
+3K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.2024—
+4K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.2024—
+5K253663Zeta Navigation SystemZeta Surgical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200510
201410
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202310
202430
202610
FIG. 1 — Lineage of K181041, 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? (3)

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
*K162375Envision 3D: Image Guidance System
Summary page 4
…valent to the following currently marketed devices: Product 510(k) Envision 3D: Image Guidance System K162375 Medtronic StealthStation System K133444 BrightMatter Navigation System Pointer K142024…
7D Surgical, Inc.2016—
*K133444Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System
Summary page 4
…ct 510(k) Envision 3D: Image Guidance System K162375 Medtronic StealthStation System K133444 BrightMatter Navigation System Pointer K142024 Tool…
Medtronic Navigation, Inc.20141
*K142024Brightmatter Navigation System
Summary page 4
…on 3D: Image Guidance System K162375 Medtronic StealthStation System K133444 BrightMatter Navigation System Pointer K142024 Tool Page 1 of 7…
Synaptive Medical, Inc.20151
†K033621Ndi Passive SpheresNorthern Digital, Inc.200428

Also cleared against K162375: 4 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195

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 18 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
  • 5 of the 7 ancestors have a recall of any class.
  • Of its descendants, K192945 (7D Surgical, Inc., 2019) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K162375.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

Indications for use as stated in the FDA summary.

Also cleared against K162375

4 other devices cite the same predicate.

  • K222291Paradigm SystemProprio, Inc. · 2023
  • K222355PathKeeper SystemPathkeeper Surgical, Ltd. · 2023
  • K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation · 2022
  • K1803527D Surgical System7D Surgical, Inc. · 2018

More from 7D Surgical, Inc.

9 FDA decisions under this applicant name. See the company

  • K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac…7D Surgical, Inc. · 2021
  • K2105557D Surgical System - Drill Guide7D Surgical, Inc. · 2021
  • K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array7D Surgical, Inc. · 2020
  • K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 2019
  • K1921407D Surgical System7D Surgical, Inc. · 2019

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/K181041 · printed Nov 5, 2026

Cite this page

510(k) Report. “K181041: 7D Surgical System Cranial Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181041

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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