510(k) · Cleared
ClearedModus Trilock 2.0/2.3/2.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medartis AG · JEY Plate, Bone
Cleared on Sep 11, 2007 as substantially equivalent to K992682 (Medartis AG, 1999) and 6 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Sep 11, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K954385 (1996). 16 ancestors in all, the oldest K943347 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 3 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 2 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 1 generation backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- This deviceK071612 Modus Trilock 2.0/2.3/2.5Medartis AG · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −3 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −2 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −1 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| 0 (this device) | K071612 | Modus Trilock 2.0/2.3/2.5 | Medartis AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K992682 | Modus 2.5 Mandibular Reconstruction SetSummary page 2…belief that the MODUS® TriLock® 2.0/2.3/2.5 System is substantially equivalent to the following predicate devices. Modus 2.5 Mandibular Resonstruction Set cleared under K992682, Modus Titanium Osteosynthesis System cleared under K050934, KLS Martin Mandibular/Reconstruction System ILcleared under K032442,… | 1999 |
| * | K050934 | Modus Titanium Osteosynthesis SystemSummary page 2…, are included in the system. The plates of the subject system are the same as plates included in the previously cleared predicate Modus Titanium Osteosynthesis System (K050934), except that the screw holes of the subject system plates are designed to accommodate TriLock Hexadrive® 6 locking screws. The… | 2005 |
| * | K032442 | KLS-Martin Mandibular/Reconstruction System IISummary page 2…dibular Resonstruction Set cleared under K992682, Modus Titanium Osteosynthesis System cleared under K050934, KLS Martin Mandibular/Reconstruction System ILcleared under K032442, Synthes 2.0 mm Locking Plate System cleared under K974555, Synthes 2.4 Universal Locking Plate System cleared under K961421, Str… | 2003 |
| * | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS)Summary page 2…anium Osteosynthesis System cleared under K050934, KLS Martin Mandibular/Reconstruction System ILcleared under K032442, Synthes 2.0 mm Locking Plate System cleared under K974555, Synthes 2.4 Universal Locking Plate System cleared under K961421, Stryker Leibinger Locking Screw Mandibular Reconstruction Plat… | 1998 |
| * | K961421 | Synthes 2.4 MM Universal Locking Plate SystemSummary page 2…ibular/Reconstruction System ILcleared under K032442, Synthes 2.0 mm Locking Plate System cleared under K974555, Synthes 2.4 Universal Locking Plate System cleared under K961421, Stryker Leibinger Locking Screw Mandibular Reconstruction Plate cleared under K000594 and OsteoMed 2.0 Locking Plate System clea… | 1996 |
| * | K000594 | Locking Screw Mandibular Reconstruction PlateSummary page 2…em cleared under K974555, Synthes 2.4 Universal Locking Plate System cleared under K961421, Stryker Leibinger Locking Screw Mandibular Reconstruction Plate cleared under K000594 and OsteoMed 2.0 Locking Plate System cleared under K030448. The plates of the subject system are the same as plates included in… | 2000 |
| * | K030448 | Osteomed 2.0 Locking Plates and ScrewsSummary page 2…e System cleared under K961421, Stryker Leibinger Locking Screw Mandibular Reconstruction Plate cleared under K000594 and OsteoMed 2.0 Locking Plate System cleared under K030448. The plates of the subject system are the same as plates included in the predicate Modus Titanium Osteosynthesis System, except… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K992682.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 MODUS® TriLock® 2.0/2.3/2.5 is intended for use in the mandible and mid-face region for osteotomies, severe fractures and comminuted fractures. These fractures may include condylar neck fractures, mandibular angle fractures, symphysis fractures, fractures of the atrophic mandible and fractures of the orbit and zygoma complex. Mandibular reconstruction may be performed with free or vascular bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071612: Modus Trilock 2.0/2.3/2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071612
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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