510(k) · Cleared
ClearedSynthes Midface Distractor
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 3, 2002 after a 76-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Sep 3, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK022005 Synthes Midface DistractorSynthes (Usa) · 2002
- Descendant · cites it directly · 3 of its ownK092743 The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010
- Descendant · 2 generations on · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · cites it directly · 0 of its ownK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK181504 Stryker Pediatric Mandibular Distractor 2Stryker · 2018
- Descendant · cites it directly · 0 of its ownK121235 Leibinger Advance Internal Midface Distraction SystemStryker · 2014
Most influential descendants
Showing 5 of 5 · See all- K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010 · cites it directly3descendants
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 2 generations on1descendant
- K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
- K181504Stryker Pediatric Mandibular Distractor 2Stryker · 2018 · 3 generations on0descendants
- K121235Leibinger Advance Internal Midface Distraction SystemStryker · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022005 | Synthes Midface Distractor | Synthes (Usa) | 2002 | — |
| +1 | K092743 | The Leibinger Advance Internal Midface Distraction System | Stryker Craniomaxillofacial | 2010 | — |
| +2 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +1 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
| +3 | K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018 | — |
| +1 | K121235 | Leibinger Advance Internal Midface Distraction System | Stryker | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092743 (Stryker Craniomaxillofacial, 2010) 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?
The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022005 · printed Nov 3, 2026
Cite this page
510(k) Report. “K022005: Synthes Midface Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022005
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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