510(k) · Cleared
Recalled · Class II · 2016Synthes (Usa) Rapid 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 Feb 27, 2007 after a 162-day review. The FDA summary names its predicate without a number. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 27, 2007
- Review
- 162 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 3
- Predicates
- 0
13 later devices descend from it, 7 citing it directly.
- This deviceK062789 Synthes (Usa) Rapid Resorbable Fixation SystemSynthes (Usa) · 2007
- Descendant · cites it directly · 4 of its ownK132920 Spirox Inex DeviceSpirox, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- Descendant · 2 generations on · 3 of its ownK223167 Spirair Nasal Septal StrapSpirair, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK233569 SeptAlignSpirair, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK112064 Resorb X-GKLS-Martin L.P. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K132920Spirox Inex DeviceSpirox, Inc. · 2014 · cites it directly4descendants
- K080862Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008 · cites it directly4descendants
- K223167Spirair Nasal Septal StrapSpirair, Inc. · 2023 · 2 generations on3descendants
- K233569SeptAlignSpirair, Inc. · 2024 · 3 generations on2descendants
- K112064Resorb X-GKLS-Martin L.P. · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062789 | Synthes (Usa) Rapid Resorbable Fixation System | Synthes (Usa) | 2007 | — |
| +1 | K132920 | Spirox Inex Device | Spirox, Inc. | 2014 | — |
| +1 | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| +2 | K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 | — |
| +3 | K233569 | SeptAlign | Spirair, Inc. | 2024 | — |
| +1 | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 (USA) Rapid Resorbable Tack System Named without a submission number | |
| * | — | Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System Named without a submission number | |
| * | — | Synthes (USA) Rapid Resorbable Cranial Clamp Named without a submission number | |
| * | — | Biomet, Inc., Lactosorb Trauma Plating System Named without a submission number |
What descends from it? (13)
See all 137 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, K132920 (Spirox, Inc., 2014) has gone furthest, with 4 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. 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 Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks 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/K062789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062789: Synthes (Usa) Rapid Resorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062789
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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