510(k) · Cleared
ClearedOsteomed Pediatric Intraoral Mandibular Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · MQN External Mandibular Fixator And/Or Distractor
Cleared on Feb 10, 2005 as substantially equivalent to K010139 (KLS-Martin L.P., 2001) and 1 other predicate after a 59-day review. Its family tree reaches back 6 generations to 1979. 5 later devices descend from it.
- Decided
- Feb 10, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K792561 (1979). 14 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 5 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 4 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 3 generations backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- 2 generations backK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- 1 generation backK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
- This deviceK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005
- Descendant · cites it directly · 2 of its ownK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- Descendant · 2 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
- Descendant · 3 generations on · 0 of its ownK181504 Stryker Pediatric Mandibular Distractor 2Stryker · 2018
Most influential descendants
Showing 5 of 5 · See all- K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006 · cites it directly2descendants
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 2 generations on1descendant
- K121502Synthes Curvilinear Distraction SystemSynthes, Inc. · 2012 · cites it directly1descendant
- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · 2 generations on0descendants
- K181504Stryker Pediatric Mandibular Distractor 2Stryker · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −5 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −4 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| −1 | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
| 0 (this device) | K043434 | Osteomed Pediatric Intraoral Mandibular Distraction System | Osteomed LP | 2005 | — |
| +1 | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed LP | 2006 | — |
| +2 | 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 | — |
| +3 | K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K010139 | Zurich Distraction SystemSummary page 1…based on similarities in intended use, material, design and operational principle to the KILS-Martin Zurich Pediatric Distraction System (K010139), the KILS-Martin Micro Mandibular Distractor and the OsteoMed lntraoral Mandibular Distraction System (K013618).… | 2001 |
| * | K013618 | Intraoral Mandibular Distraction SystemSummary page 1…atric Distraction System (K010139), the KILS-Martin Micro Mandibular Distractor and the OsteoMed lntraoral Mandibular Distraction System (K013618). Due to the similarity of materials and design to both pre-enactment and post- enactment devices… | 2002 |
| * | — | KLS-Martin Micro Mandibular Distractor Named without a submission number |
What descends from it? (5)
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 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K062851 (Osteomed LP, 2006) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K010139.
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?
Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction.
This system is intended for use in pediatric population for children under 4 years of age including infants and neonates.
The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043434: Osteomed Pediatric 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/K043434
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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