510(k) · Cleared
ClearedSynthes Craniofacial 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 Aug 14, 2002 after an 86-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Aug 14, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK021642 Synthes Craniofacial PlatesSynthes (Usa) · 2002
- Descendant · cites it directly · 1 of its ownK102656 Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa) · 2010
- Descendant · 2 generations on · 0 of its ownK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
- Descendant · cites it directly · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK091807 Medpor Fixation SystemPorex Surgical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK073307 Max-Face Maxillofacial Osteosynthesis SystemBio-Technology USA, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa) · 2010 · cites it directly1descendant
- K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · 2 generations on0descendants
- K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · cites it directly0descendants
- K091807Medpor Fixation SystemPorex Surgical, Inc. · 2010 · cites it directly0descendants
- K073307Max-Face Maxillofacial Osteosynthesis SystemBio-Technology USA, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021642 | Synthes Craniofacial Plates | Synthes (Usa) | 2002 | — |
| +1 | K102656 | Synthes Dentoalveolar Bone Fixation System | Synthes (Usa) | 2010 | — |
| +2 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
| +1 | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | Porex Surgical, Inc. | 2010 | — |
| +1 | K091807 | Medpor Fixation System | Porex Surgical, Inc. | 2010 | — |
| +1 | K073307 | Max-Face Maxillofacial Osteosynthesis System | Bio-Technology USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
4 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, K102656 (Synthes (Usa), 2010) has gone furthest, with 1 descendant 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/K021642 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021642: Synthes Craniofacial Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021642
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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