510(k) · Cleared
Recalled · 2008Newgen/Universal Mandibular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · JEY Plate, Bone
Cleared on Mar 8, 2002 as substantially equivalent to K002619 (Stryker Instruments, 2000) after a 71-day review. Its family tree reaches back 1 generation to 2000. 596 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002619 (2000). 596 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK002619 Newgen SystemStryker Instruments · 2000
- This deviceK014263 Newgen/Universal Mandibular SystemStryker Instruments · 2002
- 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 596 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 596 · 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 |
|---|---|---|---|---|---|
| −1 | K002619 | Newgen System | Stryker Instruments | 2000 | — |
| 0 (this device) | K014263 | Newgen/Universal Mandibular System | Stryker Instruments | 2002 | — |
| +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 |
|---|---|---|
| 2002 | 1 | 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 |
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 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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K002619 | Newgen SystemSummary page 1…s and mandibular reconstruction. Substantial Equivalence EQUIVALENT PRODUCTS: The Leibinger® NewGen/Universal System is substantially equivalent to the NewGen System K002619 which is a legally marketed devices. in [). Ro Regulatory Affairs Representative December 20, 2001 ¢llllr.. N… | 2000 |
What descends from it? (596)
See all 5965 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2008 | Not classified | Z-0610-2009 | Process control | A template is supposed to accompany the product, but it was not included with this lot. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 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 | — |
What is it indicated for?
The Stryker Leibinger Newgen/Universal Mandibular System is a
mandibular plate and screw system intended for stabilization and rigid
fixation of mandibular fractures and 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/K014263 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014263: Newgen/Universal Mandibular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014263
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026