510(k) · Cleared
ClearedOsteomed Intraoral 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 Jun 16, 1999 as substantially equivalent to K964649 (Howmedica Leibinger, Inc., 1997) and 1 other predicate after an 86-day review. Its family tree reaches back 4 generations to 1979. 7 later devices descend from it.
- Decided
- Jun 16, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K792561 (1979). 11 ancestors in all. 7 later devices descend from it, 1 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 backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- This deviceK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- Descendant · cites it directly · 6 of its ownK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
- Descendant · 2 generations on · 5 of its ownK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- Descendant · 3 generations on · 2 of its ownK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- Descendant · 4 generations on · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · 2 generations on · 1 of its ownK121502 Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013618Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002 · cites it directly6descendants
- K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005 · 2 generations on5descendants
- K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006 · 3 generations on2descendants
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 4 generations on1descendant
- K121502Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012 · 2 generations on1descendant
View 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 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| +1 | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
| +2 | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction System | Osteomed LP | 2005 | — |
| +3 | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed LP | 2006 | — |
| +4 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +2 | K121502 | Synthes Curvilinear Distraction System | Synthes, Inc. | 2012 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K964649 | Vazquez Diner Intraoral Distraction DeviceSummary page 1…alence for this device is based on similarities in intended use, material, design and operational principle to the 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 p… | 1997 |
| * | K972166 | Guerrero - Bell DistractorSummary page 1…tended use, material, design and operational principle to the 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, OsteoMed believes that the Os… | 1997 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013618 | Intraoral Mandibular Distraction System | 2002 | 6 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K013618 (Osteomed Corp., 2002) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K964649.
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.
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/K990944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990944: Osteomed Intraoral Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990944
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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