510(k) · Cleared

Cleared

Locking Screw Mandibular Reconstruction Plate

K000594510(k) TraditionalCleared Dec 8, 2000290-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 Dec 8, 2000 after a 290-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 446 later devices descend from it.

Decided: Dec 8, 2000
Review: 290 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 0

446 later devices descend from it, 3 citing it directly.

This deviceK000594 Locking Screw Mandibular Reconstruction PlateStryker Leibinger · 2000
Descendant · cites it directly · 444 of its ownK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
Descendant · 2 generations on · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
Descendant · 3 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
Descendant · 4 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
Descendant · 5 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled

Showing 5 of 446 descendants. See all descendants

Descendants cleared per year

2003high 54 (2024) · low 1 (2005)2026

Most influential descendants

Showing 5 of 446 · See all

K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003 · cites it directly444descendants
K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · 2 generations on435descendants
K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 3 generations on360descendants
K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 4 generations on343descendants
K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 5 generations on342descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000594	Locking Screw Mandibular Reconstruction Plate	Stryker Leibinger	2000	—
+1	K030448	Osteomed 2.0 Locking Plates and Screws	Osteomed LP	2003	—
+2	K032442	KLS-Martin Mandibular/Reconstruction System II	KLS-Martin L.P.	2003	—
+3	K040598	KLS Martin Hand Plating System	KLS-Martin L.P.	2004	—
+4	K050868	Maxlock	Orthohelix Surgical Designs, Inc.	2005	—
+5	K073624	Modular Foot System	Orthohelix Surgical Designs, Inc.	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	1	0
2006	1	0
2007	2	0
2008	2	0
2009	1	0
2010	4	0
2011	4	0
2012	16	0
2013	10	0
2014	20	0
2015	27	0
2016	17	0
2017	32	0
2018	17	0
2019	21	0
2020	28	0
2021	28	0
2022	29	0
2023	38	0
2024	54	0
2025	39	0
2026	51	0

FIG. 1 — Lineage of K000594, 2000–2026Source: 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? (446)

See all 446

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

Number	Device	Applicant	Decided	Descendants
K030448	Osteomed 2.0 Locking Plates and Screws	Osteomed LP	2003	444
K071612	Modus Trilock 2.0/2.3/2.5	Medartis AG	2007	0
K031701	Osteomed Temporary Condylar Attachment System	Osteomed LP	2004	0

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, K030448 (Osteomed LP, 2003) has gone furthest, with 444 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/K000594 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000594: Locking Screw Mandibular Reconstruction Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000594

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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