510(k) Report

510(k) · Cleared

Cleared

Waypoint Stereotactic System

K092192510(k) TraditionalCleared Feb 12, 2010206-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

FHC, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Feb 12, 2010 as substantially equivalent to K003776 (FHC, Inc., 2001) and 3 other predicates after a 206-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it.

Decided
Feb 12, 2010
Review
206 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K854886 (1986). 8 ancestors in all. 4 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2001: 1 other ancestor1998: 1 other ancestor2004: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor2023: 2 descendants cleared2014: 1 descendant cleared2024: 1 descendant clearedK854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalledK961120 · Marker System for Stereotaxic Navigation · Howmedica Leibinger, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant K961120 · Marker System for Stereotaxic Navigation · Howmedica Leibinger, Inc. · 1996K854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalled0
  1. Root · 2 generations backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
  2. 1 generation backK961120 Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996
  3. This deviceK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010
  4. Descendant · cites it directly · 1 of its ownK132611 Microtable SystemFred Haer Company, Inc. · 2014
  5. Descendant · 2 generations on · 0 of its ownK233703 Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024
  6. Descendant · cites it directly · 0 of its ownK231141 STarFix Designer Software C0265FHC, Inc. · 2023
  7. Descendant · cites it directly · 0 of its ownK223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy…Brainlab AG · 2023

Most influential descendants

Showing 4 of 4 · See all
  • K132611Microtable SystemFred Haer Company, Inc. · 2014 · cites it directly1descendant
  • K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024 · 2 generations on0descendants
  • K231141STarFix Designer Software C0265FHC, Inc. · 2023 · cites it directly0descendants
  • K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K854886Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc.19861
−1K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.1996—
0 (this device)K092192Waypoint Stereotactic SystemFHC, Inc.2010—
+1K132611Microtable SystemFred Haer Company, Inc.2014—
+2K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.2024—
+1K231141STarFix Designer Software C0265FHC, Inc.2023—
+1K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements…Brainlab AG2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199810
200110
200410
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
202320
202410
FIG. 1 — Lineage of K092192, 1986–2024Source: 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? (4)

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
*K003776Microtargeting Drive System
Summary page 1
…ial equivalence: The WayPoint™ Stereotactic System functionality is claimed to be substantially equivalent to the following: 1. FHC, Inc. microTargeting™ Drive System (K003776; decision date: February 23, 2001; product code HAW). 2. Howmedica Leibinger, Inc. Ost-Reg Marker System (K961120; decision date:…
FHC, Inc.20014
*K961120Marker System for Stereotaxic Navigation
Summary page 1
…e following: 1. FHC, Inc. microTargeting™ Drive System (K003776; decision date: February 23, 2001; product code HAW). 2. Howmedica Leibinger, Inc. Ost-Reg Marker System (K961120; decision date: May 10, 1996, product code HAW). 3. Elekta Instruments AB Leksell SurgiPlan (K080250; decision date: May 13, 2008…
Howmedica Leibinger, Inc.1996—
*K080250Leksell Surgiplan, Model 1006947
Summary page 1
…oduct code HAW). 2. Howmedica Leibinger, Inc. Ost-Reg Marker System (K961120; decision date: May 10, 1996, product code HAW). 3. Elekta Instruments AB Leksell SurgiPlan (K080250; decision date: May 13, 2008; product code HAW). 4. Elekta Instruments AB Leksell Stereotactic System (K972324; decision date: Ma…
Elekta Instrument AB2008—
*K972324Leksell Stereotactic System
Summary page 1
…uct code HAW). 3. Elekta Instruments AB Leksell SurgiPlan (K080250; decision date: May 13, 2008; product code HAW). 4. Elekta Instruments AB Leksell Stereotactic System (K972324; decision date: March 2, 1998, product code HAW). (4) Description of device: The WayPoint™ Stereotactic System, (WPS System) ac…
Elekta Instrument AB19981

Also cleared against K003776: 3 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K132611Microtable SystemFred Haer Company, Inc.20141
K231141STarFix Designer Software C0265FHC, Inc.20230
K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230

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 24 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
  • 3 of the 8 ancestors have a recall of any class.
  • Of its descendants, K132611 (Fred Haer Company, Inc., 2014) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K003776.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003776

3 other devices cite the same predicate.

  • K092562Microtargeting Star Drive System, ComponentsFHC, Inc. · 20099 recalls
  • K011775Micro Targeting Drive SystemFHC, Inc. · 20011 Class I recall
  • K011992FHC Microtargeting Drive SystemFHC, Inc. · 20016 recalls

More from FHC, Inc.

12 FDA decisions under this applicant name. See the company

  • K231141STarFix Designer Software C0265FHC, Inc. · 2023
  • K200169VFS1 Bipolar Electrosurgical GeneratorFHC, Inc. · 2020
  • K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 20181 recall
  • K121950Microtargeting XL Star Drive SystemFHC, Inc. · 2012
  • K092562Microtargeting Star Drive System, ComponentsFHC, Inc. · 20099 recalls

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/K092192 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092192: Waypoint Stereotactic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092192

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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