510(k) · Cleared
ClearedThe Leibinger Advance Internal Midface Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Craniomaxillofacial · JEY Plate, Bone
Cleared on Jan 15, 2010 as substantially equivalent to K972154 (Howmedica Leibinger, Inc., 1997) and 3 other predicates after a 129-day review. Its family tree reaches back 4 generations to 1979. 3 later devices descend from it.
- Decided
- Jan 15, 2010
- Review
- 129 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K792561 (1979). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 2 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 1 generation backK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
- This deviceK092743 The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010
- Descendant · cites it directly · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · 2 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −3 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −2 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K092743 | The Leibinger Advance Internal Midface Distraction System | Stryker Craniomaxillofacial | 2010 | — |
| +1 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +2 | K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018 | — |
| +1 | K121235 | Leibinger Advance Internal Midface Distraction System | Stryker | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K972154 | Cohen DistractorSummary page 2…stantially equivalent to other commercially available cranial and midface distraction systems. The following devices are examples of predicate systems: Cohen Distractor (K9721 54), Synthes Midface Distractor (K022005), Vazquez-Diner Intraoral Distractor (K964649) 'and Molina Orbital Malar Distractor (K(0038… | 1997 |
| * | K022005 | Synthes Midface DistractorSummary page 2…ally available cranial and midface distraction systems. The following devices are examples of predicate systems: Cohen Distractor (K9721 54), Synthes Midface Distractor (K022005), Vazquez-Diner Intraoral Distractor (K964649) 'and Molina Orbital Malar Distractor (K(003883).… | 2002 |
| * | K964649 | Vazquez Diner Intraoral Distraction DeviceSummary page 2…systems. The following devices are examples of predicate systems: Cohen Distractor (K9721 54), Synthes Midface Distractor (K022005), Vazquez-Diner Intraoral Distractor (K964649) 'and Molina Orbital Malar Distractor (K(003883).… | 1997 |
| * | K003883 | Molina Orbital Malar DistractorSummary page 2…redicate systems: Cohen Distractor (K9721 54), Synthes Midface Distractor (K022005), Vazquez-Diner Intraoral Distractor (K964649) 'and Molina Orbital Malar Distractor (K(003883). !903V… | 2001 |
What descends from it? (3)
2 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?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 12.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K133398 (Stryker, 2014) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K972154.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler). and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092743 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092743: The Leibinger Advance Internal Midface Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092743
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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