510(k) · Cleared
ClearedOral Osteodistraction Rod Appliance (Rod 5)
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 Jan 28, 2005 as substantially equivalent to K002152 (KLS-Martin L.P., 2000) after a 158-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jan 28, 2005
- Review
- 158 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002152 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002152 Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus…KLS-Martin L.P. · 2000
- This deviceK042278 Oral Osteodistraction Rod Appliance (Rod 5)Oral Osteodistraction, L.P. · 2005
- Descendant · cites it directly · 0 of its ownK080458 Mis Crest WidenerMis - Implant Technologies, Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080458Mis Crest WidenerMis - Implant Technologies, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002152 | Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction | KLS-Martin L.P. | 2000 | — |
| 0 (this device) | K042278 | Oral Osteodistraction Rod Appliance (Rod 5) | Oral Osteodistraction, L.P. | 2005 | — |
| +1 | K080458 | Mis Crest Widener | Mis - Implant Technologies, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K002152 | Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus DistractionSummary page 1…istraction Rod Appliance (ROD 5) ' Classification Name: External Mandibular Fixator and/or Distractor Product Code: MQN Predicate Device: KLS-Martin Track Distractor K002152 Intended Use: The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or… | 2000 |
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 |
|---|---|---|---|
| K080458 | Mis Crest Widener | 2008 | 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?
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 Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.
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/K042278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042278: Oral Osteodistraction Rod Appliance (Rod 5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042278
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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