510(k) · Cleared

Cleared

Luhr Mandibular/Small Fixation Implants

K950595510(k) TraditionalCleared Jul 12, 1995153-day reviewClass II21 CFR 872.4760

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

Cleared on Jul 12, 1995 after a 153-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 110 later devices descend from it.

Decided: Jul 12, 1995
Review: 153 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 0

110 later devices descend from it, 4 citing it directly.

This deviceK950595 Luhr Mandibular/Small Fixation ImplantsHowmedica Corp. · 1995
Descendant · cites it directly · 92 of its ownK962233 Twist-Off ScrewLandos, Inc. · 1996
Descendant · 2 generations on · 84 of its ownK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
Descendant · 3 generations on · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
Descendant · 2 generations on · 36 of its ownK142658 Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · Recalled
Descendant · 4 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

1996high 13 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 110 · See all

K962233Twist-Off ScrewLandos, Inc. · 1996 · cites it directly92descendants
K070039Memometal Fixos ScrewsMemometal Technologies · 2007 · 2 generations on84descendants
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · 3 generations on39descendants
K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · 2 generations on36descendants
K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 4 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950595	Luhr Mandibular/Small Fixation Implants	Howmedica Corp.	1995	—
+1	K962233	Twist-Off Screw	Landos, Inc.	1996	—
+2	K070039	Memometal Fixos Screws	Memometal Technologies	2007	—
+3	K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	1
+2	K142658	Biomet Headless Compression and Twist-off Screws	Biomet Manufacturing Corp	2014	2
+4	K123890	Acumed Cannulated Screw System	Acumed, LLC	2013	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	3	0
1998	1	0
1999	1	0
2001	1	0
2002	2	0
2003	2	0
2005	2	0
2006	1	0
2007	1	0
2010	1	0
2012	2	0
2013	2	0
2014	4	0
2015	6	0
2016	1	0
2017	6	0
2018	2	0
2019	7	0
2020	6	0
2021	5	0
2022	13	0
2023	13	0
2024	11	0
2025	5	0
2026	11	0

FIG. 1 — Lineage of K950595, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEY? 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 JEY device

#1 K252246 Leforte MMF Systemscore 15.6 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (110)

See all 110

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

Number	Device	Applicant	Decided	Descendants
K962233	Twist-Off Screw	Landos, Inc.	1996	92
K972166	Guerrero - Bell Distractor	Howmedica Leibinger, Inc.	1997	11
K972154	Cohen Distractor	Howmedica Leibinger, Inc.	1997	8
K011946	The Spin Snap-Off Screw	New Deal, S.A.	2001	6

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?

Of its descendants, K962233 (Landos, Inc., 1996) has gone furthest, with 92 descendants of its own.

How does its category compare?

All JEY devices

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

FDA decisions per year · JEY

2in 2025

2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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	9	115	0	29
2008	7	84	3	24
2009	4	121	6	93
2010	6	199	85	215
2011	5	75	0	241
2012	10	194	0	428
2013	8	126	1	766
2014	6	223	0	616
2015	7	160	0	767
2016	1	—	0	558
2017	5	190	0	568
2018	7	255	0	608
2019	6	163	0	595
2020	6	198	1	680
2021	4	299	0	451
2022	5	135	0	344
2023	2	—	0	495
2024	5	159	0	696
2025	2	—	0	1,003
2026	3	258	0	—

https://510kreport.com/device/K950595 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950595: Luhr Mandibular/Small Fixation Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950595

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026