510(k) · Cleared
ClearedDistraction Osteogenesis Rod Appliances, Models 1, 2, and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oral Osteodistraction, L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Feb 4, 2003 as substantially equivalent to K973275 (KLS-Martin L.P., 1997) and 1 other predicate after a 427-day review. Its family tree reaches back 3 generations to 1979. 1 later device descends from it.
- Decided
- Feb 4, 2003
- Review
- 427 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K792561 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 2 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 1 generation backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- This deviceK014001 Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Oral Osteodistraction, L.P. · 2003
- Descendant · cites it directly · 0 of its ownK034045 Oral Osteodistraction Distraction Rod Appliances, Rod 4Oral Osteodistraction, L.P. · 2004
Most influential descendants
Showing 1 of 1 · See all- K034045Oral Osteodistraction Distraction Rod Appliances, Rod 4Oral Osteodistraction, L.P. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −2 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −1 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| 0 (this device) | K014001 | Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3 | Oral Osteodistraction, L.P. | 2003 | — |
| +1 | K034045 | Oral Osteodistraction Distraction Rod Appliances, Rod 4 | Oral Osteodistraction, L.P. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K973275 | KLS-Martin Intraoral DistractorSummary page 1…and Rod 3) Classification Name: External Mandibular Fixator and/or Distractor Predicate Device: KLS-Martin Intraoral Distractor K973275 Synthes Mandibular Distractor K962272 Intended Use: The Oral Osteodistraction Distraction Rod Appliances… | 1997 |
| * | K962272 | Synthes Mandible DistractorSummary page 1…l Mandibular Fixator and/or Distractor Predicate Device: KLS-Martin Intraoral Distractor K973275 Synthes Mandibular Distractor K962272 Intended Use: The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034045 | Oral Osteodistraction Distraction Rod Appliances, Rod 4 | 2004 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K034045 (Oral Osteodistraction, L.P., 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K973275.
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 Oral Osteodistraction Distraction Rod Appliances 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 as stated in the FDA summary.
https://510kreport.com/device/K014001 · printed Nov 5, 2026
Cite this page
510(k) Report. “K014001: Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K014001
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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