510(k) · Cleared
ClearedIntraoral Mandibular Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Aug 14, 2002 as substantially equivalent to K990944 (Osteomed Corp., 1999) and 2 other predicates after a 282-day review. Its family tree reaches back 5 generations to 1979. 6 later devices descend from it.
- Decided
- Aug 14, 2002
- Review
- 282 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K792561 (1979). 12 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 4 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 3 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 2 generations backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- 1 generation backK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- This deviceK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
- Descendant · cites it directly · 5 of its ownK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- Descendant · 2 generations on · 2 of its ownK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- Descendant · 3 generations on · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · cites it directly · 1 of its ownK121502 Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005 · cites it directly5descendants
- K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006 · 2 generations on2descendants
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 3 generations on1descendant
- K121502Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012 · cites it directly1descendant
- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −4 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −3 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| 0 (this device) | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
| +1 | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction System | Osteomed LP | 2005 | — |
| +2 | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed LP | 2006 | — |
| +3 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +1 | K121502 | Synthes Curvilinear Distraction System | Synthes, Inc. | 2012 | — |
| +2 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K990944 | Osteomed Intraoral Distraction SystemSummary page 1…s device is based on similarities in intended use, material, design and operational principle to the OsteoMed Intraoral Distraction System (K990944), Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K9721… | 1999 |
| * | K964649 | Vazquez Diner Intraoral Distraction DeviceSummary page 1…design and operational principle to the OsteoMed Intraoral Distraction System (K990944), Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K972166). Due to the similarity of materials and desi… | 1997 |
| * | K972166 | Guerrero - Bell DistractorSummary page 1…al Distraction System (K990944), Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K972166). Due to the similarity of materials and design to both pre-enactment and post- enactment devices,… | 1997 |
What descends from it? (6)
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 23 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K043434 (Osteomed LP, 2005) has gone furthest, with 5 descendants of its own.
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?
Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.
The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013618 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013618: Intraoral Mandibular 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/K013618
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026