510(k) · Cleared
ClearedMini-H-Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geny Medical, Inc. · JEC Component, Traction, Invasive
Cleared on Dec 19, 1979 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Dec 19, 1979
- Review
- 7 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 3 citing it directly.
- This deviceK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- Descendant · cites it directly · 27 of its ownK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- Descendant · 2 generations on · 17 of its ownK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- Descendant · 3 generations on · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 8 of its ownK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- Descendant · 3 generations on · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K962272Synthes Mandible DistractorSynthes (Usa) · 1996 · cites it directly27descendants
- K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997 · 2 generations on17descendants
- K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · 3 generations on11descendants
- K973275KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997 · 2 generations on8descendants
- K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| +1 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| +2 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| +3 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| +3 | K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 313 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, K962272 (Synthes (Usa), 1996) has gone furthest, with 27 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K792561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K792561: Mini-H-Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792561
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026