510(k) · Cleared

Cleared

Leibinger - Luhr Small Orthopedic Bone Screws

K963739510(k) TraditionalCleared Jan 22, 1997127-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 Jan 22, 1997 as substantially equivalent to K761228 (Howmedica Corp., 1976) and 6 other predicates after a 127-day review. Its family tree reaches back 1 generation to 1976. 144 later devices descend from it.

Decided: Jan 22, 1997
Review: 127 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K761228 (1976). 7 ancestors in all. 144 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
This deviceK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
Descendant · cites it directly · 143 of its ownK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
Descendant · 2 generations on · 141 of its ownK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
Descendant · 3 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
Descendant · 4 generations on · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
Descendant · 5 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

1997high 17 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 144 · See all

K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997 · cites it directly143descendants
K974785Auto-Drive Bone ScrewOsteomed Corp. · 1998 · 2 generations on141descendants
K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 3 generations on117descendants
K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · 4 generations on101descendants
K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 5 generations on100descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K761228	Luhr Mandibular Compression-Screw System	Howmedica Corp.	1976	—
0 (this device)	K963739	Leibinger - Luhr Small Orthopedic Bone Screws	Howmedica Leibinger, Inc.	1997	—
+1	K970912	Leibinger Self-Drilling Screw	Howmedica Leibinger, Inc.	1997	—
+2	K974785	Auto-Drive Bone Screw	Osteomed Corp.	1998	—
+3	K013954	Lorenz Self Drilling Screws	Walter Lorenz Surgical, Inc.	2002	—
+4	K032228	Lorenz 2.4 Self Drilling Screws	Walter Lorenz Surgical, Inc.	2003	—
+5	K033740	Lorenz Sternal Closure System	Walter Lorenz Surgical, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	2	0
1988	1	0
1991	1	0
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2002	3	0
2003	6	0
2006	3	0
2007	3	0
2008	1	0
2010	2	0
2011	5	0
2012	6	0
2013	4	0
2014	8	0
2015	10	0
2016	8	0
2017	1	0
2018	6	0
2019	4	0
2020	4	0
2021	3	0
2022	7	0
2023	10	0
2024	16	0
2025	17	0
2026	14	0

FIG. 1 — Lineage of K963739, 1976–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
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What was it cleared against? (7)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K761228	Luhr Mandibular Compression-Screw System Summary page 1 …ingle use only. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibing…	Howmedica Corp.	1976	—
*	K882454	Luhr Micro System Summary page 1 …e only. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibinger Foref…	Howmedica Corp.	1988	—
*	K913355	Luhr Pan Fixation System Summary page 1 …Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibinger Forefoot Recon…	Howmedica Corp.	1991	—
*	K935448	Luhr Mini Bone Screw and Z Plate Summary page 1 …ce for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction…	Howmedica Corp.	1994	—
*	K854886	Wuerzburg Titanium Mini Bone Plates & Bone Screws Summary page 1 …rities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr®, Wurzbur…	Walter Lorenz Surgical, Inc.	1986	1
*	K862482	Steinhauser Titanium Mini Bone Plates & Screws Summary page 1 …and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr®, Wurzburg°D and Steinhauser”, Profyle and Forefo…	Walter Lorenz Surgical, Inc.	1986	—
*	K961485	Forefoot Reconstruction System Summary page 1 …61228,K882454, K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser™ Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr®, Wurzburg°D and Steinhauser”, Profyle and Forefoot bone screws are intended for use as small bone screws in internal…	Howmedica Corp.	1996	—

Also cleared against K761228: 1 other device →

What descends from it? (144)

See all 144

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

Number	Device	Applicant	Decided	Descendants
K970912	Leibinger Self-Drilling Screw	Howmedica Leibinger, Inc.	1997	143

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 7 ancestors has a recall of any class.
Of its descendants, K970912 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 143 descendants of its own.
1 other device also cites its predicate K761228.

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

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

It is intended for use in internal fixation of small bones including the hand and foot 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.

https://510kreport.com/device/K963739 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963739: Leibinger - Luhr Small Orthopedic Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963739

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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