510(k) · Cleared

Cleared

Newgen System

K002619510(k) TraditionalCleared Nov 16, 200085-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 Nov 16, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 597 later devices descend from it.

Decided: Nov 16, 2000
Review: 85 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 0

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

This deviceK002619 Newgen SystemStryker Instruments · 2000
Descendant · cites it directly · 596 of its ownK014263 Newgen/Universal Mandibular SystemStryker Instruments · 2002 · Recalled
Descendant · 2 generations on · 444 of its ownK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
Descendant · 3 generations on · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
Descendant · 4 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
Descendant · 5 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005

Showing 5 of 597 descendants. See all descendants

Descendants cleared per year

2002high 65 (2024) · low 2 (2002)2026

Most influential descendants

Showing 5 of 597 · See all

K014263Newgen/Universal Mandibular SystemStryker Instruments · 2002 · cites it directly596descendants
K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003 · 2 generations on444descendants
K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · 3 generations on435descendants
K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 4 generations on360descendants
K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 5 generations on343descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002619	Newgen System	Stryker Instruments	2000	—
+1	K014263	Newgen/Universal Mandibular System	Stryker Instruments	2002	1
+2	K030448	Osteomed 2.0 Locking Plates and Screws	Osteomed LP	2003	—
+3	K032442	KLS-Martin Mandibular/Reconstruction System II	KLS-Martin L.P.	2003	—
+4	K040598	KLS Martin Hand Plating System	KLS-Martin L.P.	2004	—
+5	K050868	Maxlock	Orthohelix Surgical Designs, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	0
2004	4	0
2005	2	0
2006	3	0
2007	4	0
2008	3	0
2009	3	0
2010	11	0
2011	8	0
2012	20	0
2013	19	0
2014	30	0
2015	33	0
2016	24	0
2017	46	0
2018	29	0
2019	28	0
2020	35	0
2021	32	0
2022	40	0
2023	45	0
2024	65	0
2025	48	0
2026	59	0

FIG. 1 — Lineage of K002619, 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? (597)

See all 597

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

Number	Device	Applicant	Decided	Descendants
K014263	Newgen/Universal Mandibular System	Stryker Instruments	2002	596
K022185	Universal CMF System	Stryker Instruments	2002	33
K032520	Ortrautek Trauma System	Tekka	2003	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, K014263 (Stryker Instruments, 2002) has gone furthest, with 596 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/K002619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002619: Newgen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002619

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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