510(k) Report

510(k) · Cleared

Cleared

Marker System for Stereotaxic Navigation

K961120510(k) TraditionalCleared May 10, 199650-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

Howmedica Leibinger, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on May 10, 1996 as substantially equivalent to K892425 (Leibinger & Fischer, Ltd., 1990) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1986. 17 later devices descend from it.

Decided
May 10, 1996
Review
50 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K854886 (1986). 2 ancestors in all. 17 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor1997: 1 descendant cleared2001: 1 descendant cleared2010: 2 descendants cleared1998: 1 descendant cleared2016: 2 descendants cleared2023: 3 descendants cleared2014: 1 descendant cleared1999: 1 descendant cleared2024: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant clearedK854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalled0+5
  1. Root · 1 generation backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
  2. This deviceK961120 Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996
  3. Descendant · cites it directly · 8 of its ownK982463 Extracranial Radiotherapy SystemHowmedica, Inc. · 1998
  4. Descendant · 2 generations on · 7 of its ownK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
  5. Descendant · 3 generations on · 6 of its ownK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
  6. Descendant · 4 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
  7. Descendant · cites it directly · 4 of its ownK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12001: 12010: 22013: 12014: 12016: 22017: 12018: 12021: 12023: 32024: 1
1997high 3 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all
  • K982463Extracranial Radiotherapy SystemHowmedica, Inc. · 1998 · cites it directly8descendants
  • K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999 · 2 generations on7descendants
  • K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010 · 3 generations on6descendants
  • K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 4 generations on5descendants
  • K092192Waypoint Stereotactic SystemFHC, Inc. · 2010 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K854886Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc.19861
0 (this device)K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.1996—
+1K982463Extracranial Radiotherapy SystemHowmedica, Inc.1998—
+2K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)1999—
+3K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp.2010—
+4K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.2013—
+1K092192Waypoint Stereotactic SystemFHC, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200110
201020
201310
201410
201620
201710
201810
202110
202330
202410
FIG. 1 — Lineage of K961120, 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? (2)

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
*K892425STP Complete Module Set
Summary page 2
…edica Leibinger, Inc. Summary of Safety and Effectiveness 510(k) Premarket Notification: Marker System for Stereotaxic Navigation 3.0 Predicate Device Identification K892425 K854886 Stereotaxic [nstrument Bone Screw 84HAW 87THWC II II 882.4560 888.3040 4.0 Product Description 4.1 Background Ster…
Leibinger & Fischer, Ltd.1990—
*K854886Wuerzburg Titanium Mini Bone Plates & Bone Screws
Summary page 2
…ibinger, Inc. Summary of Safety and Effectiveness 510(k) Premarket Notification: Marker System for Stereotaxic Navigation 3.0 Predicate Device Identification K892425 K854886 Stereotaxic [nstrument Bone Screw 84HAW 87THWC II II 882.4560 888.3040 4.0 Product Description 4.1 Background Stereotaxy r…
Walter Lorenz Surgical, Inc.19861

Also cleared against K892425: 5 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K982463Extracranial Radiotherapy SystemHowmedica, Inc.19988
K092192Waypoint Stereotactic SystemFHC, Inc.20104
K010427Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc.20011
K963502Csco Forehead Fixation SystemHowmedica Corp.19970

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K982463 (Howmedica, Inc., 1998) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K892425.

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—

What is it indicated for?

The Marker System is intended for establishing fixed reference points in patients requiring stereotactic surgery. Examples of situations necessitating stereotaxy could include patients in need of biopsy, resection, lesion generation, implantation of radioisotopes, and small field external beam radiotherapy.

The Marker System can be used as an accessory with all currently marketed Howmedica Leibinger® stereotactic systems and can also be used with frameless navigation systems from other manufacturers.

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 K892425

5 other devices cite the same predicate.

  • K991706Virtuoso-Stereotaxic Planning SoftwareStryker Corp. · 1999
  • K982463Extracranial Radiotherapy SystemHowmedica, Inc. · 1998
  • K972324Leksell Stereotactic SystemElekta Instrument AB · 19981 recall
  • K961484Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco) · 1996
  • K946033Leibinger Stereoplan Plus Sterotactic Treatment Plan Ing Software PackageLeibinger GmbH · 1995

More from Howmedica Leibinger, Inc.

11 FDA decisions under this applicant name. See the company

  • K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  • K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997
  • K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
  • K961719Epitec Titanium Implant System for the Surgical Anchoring of Facial ProsthesesHowmedica Leibinger, Inc. · 1997
  • K963030Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997

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/K961120 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961120: Marker System for Stereotaxic Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961120

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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