510(k) · Cleared
Recalled · Class II · 2016Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JEY Plate, Bone
Cleared on Apr 8, 2003 after a 90-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 8, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 3
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK030069 Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation SystemSynthes (Usa) · 2003
- Descendant · cites it directly · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK102656 Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa) · 2010
- Descendant · cites it directly · 1 of its ownK073115 OrthomeshSynthes (Usa) · 2008
- Descendant · 2 generations on · 0 of its ownK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · cites it directly3descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 2 generations on2descendants
- K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa) · 2010 · cites it directly1descendant
- K073115OrthomeshSynthes (Usa) · 2008 · cites it directly1descendant
- K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030069 | Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System | Synthes (Usa) | 2003 | — |
| +1 | K061881 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2007 | — |
| +2 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +1 | K102656 | Synthes Dentoalveolar Bone Fixation System | Synthes (Usa) | 2010 | — |
| +1 | K073115 | Orthomesh | Synthes (Usa) | 2008 | — |
| +2 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Lorenz LactoSorb Trauma Plating System (Biomet) Named without a submission number | |
| * | — | Synthes Resorbable Fixation System, Poly (L/DL-lactide) Named without a submission number |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2016 | Class II | Z-1919-2016 | Under Investigation by firm | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
| May 2, 2016 | Class II | Z-1920-2016 | Under Investigation by firm | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
| May 2, 2016 | Class II | Z-1918-2016 | Under Investigation by firm | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061881 (Takiron Co., Ltd., 2007) has gone furthest, with 3 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?
Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System devices (Plates, Meshes, Sheets, and Screws) are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets and Screws may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030069: Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030069
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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