510(k) Report

510(k) · Cleared

Cleared

Leibinger Self-Drilling Screw

K970912510(k) TraditionalCleared Oct 1, 1997203-day reviewClass II21 CFR 888.3040

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

Howmedica Leibinger, Inc. · HWC Screw, Fixation, Bone

Cleared on Oct 1, 1997 as substantially equivalent to K944565 (KLS-Martin L.P., 1994) and 3 other predicates after a 203-day review. Its family tree reaches back 2 generations to 1976. 143 later devices descend from it.

Decided
Oct 1, 1997
Review
203 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K761228 (1976). 11 ancestors in all. 143 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 2 other ancestors1994: 2 other ancestors1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors1999: 1 descendant cleared2002: 3 descendants cleared2008: 1 descendant cleared1998: 1 descendant cleared2007: 3 descendants cleared2003: 6 descendants cleared2014: 8 descendants cleared2011: 5 descendants cleared2015: 10 descendants cleared2013: 4 descendants cleared2006: 3 descendants cleared2012: 6 descendants cleared2010: 2 descendants cleared2018: 6 descendants cleared2020: 4 descendants cleared2019: 4 descendants cleared2025: 17 descendants cleared2023: 10 descendants cleared2021: 3 descendants cleared2022: 7 descendants cleared2016: 8 descendants cleared2017: 1 descendant cleared2024: 16 descendants cleared2026: 14 descendants clearedK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 12 descendants4 generations forward: 14 descendants5 generations forward: 17 descendants6 generations forward: 15 descendants7 generations forward: 19 descendants8 generations forward: 19 descendants9 generations forward: 22 descendants10 generations forward: 9 descendants11 generations forward: 1 descendant12 generations forward: 1 descendant K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 19760+5+10
  1. Root · 2 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 1 generation backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. This deviceK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. Descendant · cites it directly · 141 of its ownK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. Descendant · 2 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. Descendant · 3 generations on · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. Descendant · 4 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. Descendant · 3 generations on · 87 of its ownK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12002: 32003: 62006: 32007: 32008: 12010: 22011: 52012: 62013: 42014: 82015: 102016: 82017: 12018: 62019: 42020: 42021: 32022: 72023: 102024: 162025: 172026: 14
1998high 17 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 143 · See all
  • K974785Auto-Drive Bone ScrewOsteomed Corp. · 1998 · cites it directly141descendants
  • K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 2 generations on117descendants
  • K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · 3 generations on101descendants
  • K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 4 generations on100descendants
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006 · 3 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−1K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
0 (this device)K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
+1K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
+2K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
+3K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
+4K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
+3K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199110
199420
199620
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200230
200360
200630
200730
200810
201020
201150
201260
201340
201480
2015100
201680
201710
201860
201940
202040
202130
202270
2023100
2024160
2025170
2026140
FIG. 1 — Lineage of K970912, 1976–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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
*K944565KLS-Martin Micro Osteosythesis System (1.5MM)
Summary page 1
…-8 mm, Equivalence for this device is based on similanties in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-Frec™ Screw [K944565] and the Leibinger® Luhr® Small Bone Screws [K963739, K963740 and K963741). Each of the screw systems is intended for use in fixa…
KLS-Martin L.P.1994—
*K963739Leibinger - Luhr Small Orthopedic Bone Screws
Summary page 1
…anties in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-Frec™ Screw [K944565] and the Leibinger® Luhr® Small Bone Screws [K963739, K963740 and K963741). Each of the screw systems is intended for use in fixation of small bones secondary to trauma or for recons…
Howmedica Leibinger, Inc.1997—
*K963740Leibinger - Luhr Small Mandibular Bone Screws
Summary page 1
…intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-Frec™ Screw [K944565] and the Leibinger® Luhr® Small Bone Screws [K963739, K963740 and K963741). Each of the screw systems is intended for use in fixation of small bones secondary to trauma or for reconstruction.…
Howmedica Leibinger, Inc.1996—
*K963741Leibinger Luhr Small Craniomaxillofacial Bone Screws
Summary page 1
…e, material, design and operational principle to the KLS Martin Centre-Drive Drill-Frec™ Screw [K944565] and the Leibinger® Luhr® Small Bone Screws [K963739, K963740 and K963741). Each of the screw systems is intended for use in fixation of small bones secondary to trauma or for reconstruction. The Leibing…
Howmedica Leibinger, Inc.1997—

Also cleared against K944565: 14 other devices →

What descends from it? (143)

See all 143

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

NumberDeviceApplicantDecidedDescendants
K974785Auto-Drive Bone ScrewOsteomed Corp.1998141
K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224
K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085
K992106Modus System Self-Drilling ScrewsMedartis AG19990

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 21 years and passes through 2 companies; a new generation was cleared every 20.1 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K974785 (Osteomed Corp., 1998) has gone furthest, with 141 descendants of its own.
  • 14 other devices also cite its predicate K944565.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

This device is intended for use in internal fixation of small bones including the

craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

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 K944565

14 other devices cite the same predicate.

  • K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM)…KLS-Martin L.P. · 2025
  • K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
  • K112557Stryker Universal Neuro 3 SystemStryker · 2012
  • K073307Max-Face Maxillofacial Osteosynthesis SystemBio-Technology USA, Inc. · 2008
  • K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation SystemBioplate, Inc. · 20081 recall
  • K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006

More from Howmedica Leibinger, Inc.

11 FDA decisions under this applicant name. See the company

  • K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
  • K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997
  • K961719Epitec Titanium Implant System for the Surgical Anchoring of Facial ProsthesesHowmedica Leibinger, Inc. · 1997
  • K970911Lee PlateHowmedica Leibinger, Inc. · 1997
  • K963030Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997

Recent decisions in HWC

The HWC category page

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https://510kreport.com/device/K970912 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970912: Leibinger Self-Drilling Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970912

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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