510(k) · Cleared

Cleared

Leibinger Luhr Small Craniomaxillofacial Bone Screws

K963741510(k) TraditionalCleared Feb 6, 1997142-day reviewClass II21 CFR 888.3030

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

Howmedica Leibinger, Inc. · HRS Plate, Fixation, Bone

Cleared on Feb 6, 1997 as substantially equivalent to K761228 (Howmedica Corp., 1976) and 6 other predicates after a 142-day review. Its family tree reaches back 1 generation to 1976. 188 later devices descend from it.

Decided: Feb 6, 1997
Review: 142 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K761228 (1976). 7 ancestors in all. 188 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
This deviceK963741 Leibinger Luhr Small Craniomaxillofacial 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 188 descendants. See all descendants

Descendants cleared per year

1997high 23 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 188 · 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)	K963741	Leibinger Luhr Small Craniomaxillofacial 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
2004	1	0
2005	1	0
2006	3	0
2007	3	0
2008	2	0
2009	2	0
2010	5	0
2011	5	0
2012	11	0
2013	7	0
2014	8	0
2015	11	0
2016	10	0
2017	2	0
2018	10	0
2019	7	0
2020	5	0
2021	4	0
2022	8	0
2023	13	0
2024	23	0
2025	17	0
2026	18	0

FIG. 1 — Lineage of K963741, 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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°D Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibin…	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°D Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Fore…	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°D Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reco…	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°D Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstructio…	Howmedica Corp.	1994	—
*	K854886	Wuerzburg Titanium Mini Bone Plates & Bone Screws Summary page 1 …ities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454. K913355, K935448); the Wurzburg°D 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°D Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr®, Wurzburgi and Steinhauser®, and Forefoot bone s…	Walter Lorenz Surgical, Inc.	1986	—
*	K961485	Forefoot Reconstruction System Summary page 1 …1228,K882454. K913355, K935448); the Wurzburg°D Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr®, Wurzburgi and Steinhauser®, and Forefoot bone screws are intended for use as small bone screws in internal fixation…	Howmedica Corp.	1996	—

Also cleared against K761228: 1 other device →

What descends from it? (188)

See all 188

2 later devices cite 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
K032534	Synthes Afs	Synthes Spine	2004	43

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 HRS devices

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

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

It is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton 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/K963741 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963741: Leibinger Luhr Small Craniomaxillofacial Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963741

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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