510(k) · Cleared
ClearedSynthes Mandible Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MQN External Mandibular Fixator And/Or Distractor
Cleared on Aug 30, 1996 as substantially equivalent to K792561 (Geny Medical, Inc., 1979) after a 78-day review. Its family tree reaches back 1 generation to 1979. 27 later devices descend from it.
- Decided
- Aug 30, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K792561 (1979). 27 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- This deviceK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- Descendant · cites it directly · 17 of its ownK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · cites it directly · 8 of its ownK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- Descendant · 2 generations on · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 7 of its ownK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997 · cites it directly17descendants
- K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on11descendants
- K973275KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997 · cites it directly8descendants
- K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on8descendants
- K990944Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| 0 (this device) | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| +1 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +1 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| +2 | K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 5 | 0 |
| 1998 | 2 | 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 |
| 2022 | 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 MQN? 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 MQN device
- #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K792561 | Mini-H-FixationSummary page 1…ela Silvestri 1690 Russell Road (610) 647-9700 Paoli, PA 19301 June 1996 Synthes Mandible Distractor is compared to the Howmedica’s Hoffmann® Mini- Lengthening Fixator (K792561). The device is similar to Howmedica’s Mandibular Bone Distractor (K945674). The Synthes Mandible Distractor is intended to be u… | 1979 |
| † | K945674 | Mandibular Bone Distractor | 1995 |
What descends from it? (27)
See all 274 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?
How does its category compare?
All MQN devicesMQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, 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 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
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/K962272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962272: Synthes Mandible Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962272
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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