510(k) · Cleared
ClearedSynthes 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 24, 1998 as substantially equivalent to K953806 (Synthes (Usa), 1996) and 2 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1996. 89 later devices descend from it.
- Decided
- Feb 24, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K955729 (1996). 3 ancestors in all. 89 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK955729 Lactosorb Trauma Plating SystemPoly-Medics,Inc. · 1996 · Recalled
- This deviceK974554 Synthes Resorbable Fixation SystemSynthes (Usa) · 1998
- Descendant · cites it directly · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- Descendant · 2 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- Descendant · cites it directly · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- Descendant · 2 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · cites it directly86descendants
- K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 2 generations on79descendants
- K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants
- K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 2 generations on65descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955729 | Lactosorb Trauma Plating System | Poly-Medics,Inc. | 1996 | 1 |
| 0 (this device) | K974554 | Synthes Resorbable Fixation System | Synthes (Usa) | 1998 | — |
| +1 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| +2 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| +1 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| +2 | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| +3 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K512932 | Synthes Maxillofacial Titanium Micro Set Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K953806 | Synthes (Usa) Midfacial SystemSummary page 1…hle Fixation System is substantially equivalent to Class II meuallic implants, such as Synthes Maxillofacial Titanium Micro Set (K$12932), and Syntlics Midfacial System (K953806). Synthes (U.S.A)) Resurbable Fixation System is also substantially equivalent to other absorbable platcs and screws, such as the… | 1996 |
| * | K955729 | Lactosorb Trauma Plating System Our OCR of the scanned summary read K255729, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lorenz LactoSorb Trauma Plating System”. | 1996 |
| * | K960988 | Lactosorb Trauma Plating SystemSummary page 1…(U.S.A)) Resurbable Fixation System is also substantially equivalent to other absorbable platcs and screws, such as the Lorenz LactoSorb® Trauma Plating System (K255729, K960988), which is manufactured from 82:18 poly(L-lactide-co-glycolide) $821¢20191:731 STHINAS L0:CT (144186 07- T WIAL… | 1996 |
What descends from it? (89)
See all 895 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | 1998 | 86 |
| K011590 | Resorb-X Resorbable Plating System | 2002 | 73 |
| K012486 | Osteomed Bioresorbable Fixation System | 2002 | 0 |
| K994060 | The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, Biolactate | 2001 | 0 |
| K982951 | Imtec Biopin | 1999 | 0 |
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?
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 is intended for fractures of the craniofaciai skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbitul arcas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and recvusttuctive procedures of the midface or craniofacial skeleton. Do not use in the mandible.
Synthes Resarbable Fixation System is not intended for: 1) areas with active infection; 2) patient conditions including: blnnd supply limitations, insufficient quantity of yuality of bonc, or latent infections. ‘I'hic device is not designed for use in the mandible or fur use in full load bearing procedures
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/K974554 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974554: Synthes 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/K974554
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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