510(k) · Cleared
ClearedSynthes (Usa) New/Sterial Orbital Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JEY Plate, Bone
Cleared on Sep 3, 2003 after an 89-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 3, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK031761 Synthes (Usa) New/Sterial Orbital PlatesSynthes (Usa) · 2003
- Descendant · cites it directly · 0 of its ownK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
- Descendant · cites it directly · 0 of its ownK180249 OmniPore DUROMAX Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA · 2018
- Descendant · cites it directly · 0 of its ownK140978 Osteomed Low Profile Orbital Floor Plate SystemOsteomed · 2014
Most influential descendants
Showing 3 of 3 · See all- K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
- K180249OmniPore DUROMAX Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA · 2018 · cites it directly0descendants
- K140978Osteomed Low Profile Orbital Floor Plate SystemOsteomed · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031761 | Synthes (Usa) New/Sterial Orbital Plates | Synthes (Usa) | 2003 | — |
| +1 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
| +1 | K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2018 | — |
| +1 | K140978 | Osteomed Low Profile Orbital Floor Plate System | Osteomed | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | — | Synthes Maxillofacial Titanium Micro Set Named without a submission number | |
| * | — | Synthes Orbital Mesh Plates Named without a submission number |
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192655 (Synthes (USA) Products, LLC, 2019) has gone furthest, with 0 descendants of its own.
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 Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031761: Synthes (Usa) New/Sterial Orbital Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031761
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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