510(k) · Cleared
ClearedSynthes (Usa) Midfacial 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 Mar 8, 1996 after a 211-day review. The FDA summary names its predicate without a number. 240 later devices descend from it.
- Decided
- Mar 8, 1996
- Review
- 211 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
240 later devices descend from it, 8 citing it directly.
- This deviceK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- Descendant · cites it directly · 171 of its ownK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- Descendant · 2 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- Descendant · 3 generations on · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- Descendant · 4 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- Descendant · cites it directly · 89 of its ownK974554 Synthes Resorbable Fixation SystemSynthes (Usa) · 1998
Showing 5 of 240 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 240 · See all- K983485Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998 · cites it directly171descendants
- K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 2 generations on117descendants
- K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · 3 generations on101descendants
- K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 4 generations on100descendants
- K974554Synthes Resorbable Fixation SystemSynthes (Usa) · 1998 · cites it directly89descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| +1 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| +2 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| +3 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| +4 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| +1 | K974554 | Synthes Resorbable Fixation System | Synthes (Usa) | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 10 | 0 |
| 2013 | 5 | 0 |
| 2014 | 14 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 10 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 13 | 0 |
| 2023 | 12 | 0 |
| 2024 | 18 | 0 |
| 2025 | 18 | 0 |
| 2026 | 18 | 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? (1)
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 |
|---|---|---|---|
| * | — | Howmedica Luhr Pan Fixation System Named without a submission number |
What descends from it? (240)
See all 2408 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983485 | Synthes 1.3 MM Self-Drilling Screw | 1998 | 171 |
| K974554 | Synthes Resorbable Fixation System | 1998 | 89 |
| K022185 | Universal CMF System | 2002 | 33 |
| K972166 | Guerrero - Bell Distractor | 1997 | 11 |
| K980199 | Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws | 1998 | 10 |
| K972154 | Cohen Distractor | 1997 | 8 |
| K974206 | Synthes Cranial Spring Clip (CSC) | 1998 | 6 |
| K140037 | Optimus CMF System | 2015 | 2 |
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, K983485 (Synthes (Usa), 1998) has gone furthest, with 171 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?
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953806: Synthes (Usa) Midfacial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953806
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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