510(k) Report

510(k) · Cleared

Cleared

Leibinger Imf Screw

K963030510(k) TraditionalCleared Apr 11, 1997249-day reviewClass II21 CFR 872.3640

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

Howmedica Leibinger, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Apr 11, 1997 as substantially equivalent to K820944 (Unisplint Corp., 1982) and 2 other predicates after a 249-day review. Its family tree reaches back 1 generation to 1982. 25 later devices descend from it.

Decided
Apr 11, 1997
Review
249 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K820944 (1982). 3 ancestors in all. 25 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1991: 1 other ancestor2005: 3 descendants cleared1999: 2 descendants cleared2015: 3 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant cleared2004: 2 descendants cleared2007: 1 descendant cleared2024: 2 descendants cleared2009: 1 descendant cleared2014: 2 descendants cleared2026: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant clearedK820944 · Dental Arch Bar · Unisplint Corp. · 198219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 8 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K820944 · Dental Arch Bar · Unisplint Corp. · 19820+5
  1. Root · 1 generation backK820944 Dental Arch BarUnisplint Corp. · 1982
  2. This deviceK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
  3. Descendant · cites it directly · 11 of its ownK050535 Stryker MMF ScrewStryker Instruments · 2005
  4. Descendant · 2 generations on · 10 of its ownK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
  5. Descendant · cites it directly · 9 of its ownK983728 Lorenz Imf ScrewWalter Lorenz Surgical, Inc. · 1999
  6. Descendant · cites it directly · 8 of its ownK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999
  7. Descendant · 2 generations on · 7 of its ownK040983 Lorenz Self-Drilling Imf ScrewWalter Lorenz Surgical, Inc. · 2004

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

1999: 22004: 22005: 32007: 12009: 12012: 12014: 22015: 32016: 12018: 12019: 12021: 12023: 12024: 22025: 12026: 2
1999high 3 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 25 · See all
  • K050535Stryker MMF ScrewStryker Instruments · 2005 · cites it directly11descendants
  • K122313Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012 · 2 generations on10descendants
  • K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc. · 1999 · cites it directly9descendants
  • K980760KLS-Martin MMF ScrewKLS-Martin L.P. · 1999 · cites it directly8descendants
  • K040983Lorenz Self-Drilling Imf ScrewWalter Lorenz Surgical, Inc. · 2004 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K820944Dental Arch BarUnisplint Corp.1982—
0 (this device)K963030Leibinger Imf ScrewHowmedica Leibinger, Inc.1997—
+1K050535Stryker MMF ScrewStryker Instruments2005—
+2K122313Stryker Universal Smartlock Hybrid MMF SystemStryker2012—
+1K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc.1999—
+1K980760KLS-Martin MMF ScrewKLS-Martin L.P.1999—
+2K040983Lorenz Self-Drilling Imf ScrewWalter Lorenz Surgical, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200420
200530
200710
200910
201210
201420
201530
201610
201810
201910
202110
202310
202420
202510
202620
FIG. 1 — Lineage of K963030, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DZE? 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 DZE device

  1. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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
*K820944Dental Arch Bar
Summary page 3
…for single use only. Equivalence for this device is based on similarities in intended use. material. design and operational principle to the Unisplint Dental Arch Bar (K820944); the Synthes Minihook and Cortical Screw (K# Unknown): the Synthes Cortical Bone Screw (K912932); and the Leibinger®-Luhr® Small…
Unisplint Corp.1982—
*K912932Synthes Maxillofacial Titanium Micro Set
Summary page 3
…rial. design and operational principle to the Unisplint Dental Arch Bar (K820944); the Synthes Minihook and Cortical Screw (K# Unknown): the Synthes Cortical Bone Screw (K912932); and the Leibinger®-Luhr® Small Mandibular Bone Screws (K963740). The Dental Arch Bars, Minihook and Cortical Screw and Cortical…
Synthes (Usa)1991—
*K963740Leibinger - Luhr Small Mandibular Bone Screws
Cleared while this submission was under review
Summary page 3
…ch Bar (K820944); the Synthes Minihook and Cortical Screw (K# Unknown): the Synthes Cortical Bone Screw (K912932); and the Leibinger®-Luhr® Small Mandibular Bone Screws (K963740). The Dental Arch Bars, Minihook and Cortical Screw and Cortical Bone Screw are intended for use in maxillomandibular fixation to…
Howmedica Leibinger, Inc.1996—
*—Synthes Minihook and Cortical Screw
Named without a submission number
—

Also cleared against K820944: 3 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K050535Stryker MMF ScrewStryker Instruments200511
K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc.19999
K980760KLS-Martin MMF ScrewKLS-Martin L.P.19998
K140037Optimus CMF SystemOsteonic Co., Ltd.20152
K050478Medicon Imf-Orion ScrewsMedicon EG20050

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K050535 (Stryker Instruments, 2005) has gone furthest, with 11 descendants of its own.
  • 3 other devices also cite its predicate K820944.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

Also cleared against K820944

3 other devices cite the same predicate.

  • K061271Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
  • K031207Safety Release Arch Bar KitCasey Surgical, LLC · 2003
  • K991004Synthes Quick Lock Imf SystemSynthes (Usa) · 1999

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
  • K970911Lee PlateHowmedica Leibinger, Inc. · 1997

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K963030 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963030: Leibinger Imf Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963030

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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