510(k) · Cleared
ClearedSynthes (Usa) 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 Sep 6, 2002 after an 86-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 6, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK021928 Synthes (Usa) Resorbable Fixation SystemSynthes (Usa) · 2002
- Descendant · cites it directly · 4 of its ownK132920 Spirox Inex DeviceSpirox, Inc. · 2014
- 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 · 4 generations on · 1 of its ownK251790 SeptAlignSpirair, Inc. · 2026
- Descendant · 5 generations on · 0 of its ownK260620 SeptAlign (SPLN001)Spirair, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K132920Spirox Inex DeviceSpirox, Inc. · 2014 · cites it directly4descendants
- K223167Spirair Nasal Septal StrapSpirair, Inc. · 2023 · 2 generations on3descendants
- K233569SeptAlignSpirair, Inc. · 2024 · 3 generations on2descendants
- K251790SeptAlignSpirair, Inc. · 2026 · 4 generations on1descendant
- K260620SeptAlign (SPLN001)Spirair, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021928 | Synthes (Usa) Resorbable Fixation System | Synthes (Usa) | 2002 | — |
| +1 | K132920 | Spirox Inex Device | Spirox, Inc. | 2014 | — |
| +2 | K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 | — |
| +3 | K233569 | SeptAlign | Spirair, Inc. | 2024 | — |
| +4 | K251790 | SeptAlign | Spirair, Inc. | 2026 | — |
| +5 | K260620 | SeptAlign (SPLN001) | Spirair, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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 Resorbable Fixation System Named without a submission number | |
| * | — | Synthes Resorbable Tack System Named without a submission number | |
| * | — | Synthes Resorbable Meshes and Sheets Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132920 | Spirox Inex Device | 2014 | 4 |
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, 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.
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 Resorbable Fixation System devices (Plates, Meshes, Sheets, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021928: Synthes (Usa) 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/K021928
Report an extraction error
Are you the manufacturer?
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