510(k) · Cleared
ClearedOral Osteodistraction Distraction Rod Appliances, Rod 4
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 Mar 23, 2004 as substantially equivalent to K972047 (KLS-Martin L.P., 1997) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Mar 23, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K792561 (1979). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 2 generations backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- 1 generation backK014001 Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Oral Osteodistraction, L.P. · 2003
- This deviceK034045 Oral Osteodistraction Distraction Rod Appliances, Rod 4Oral Osteodistraction, L.P. · 2004
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 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| −1 | K014001 | Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3 | Oral Osteodistraction, L.P. | 2003 | — |
| 0 (this device) | K034045 | Oral Osteodistraction Distraction Rod Appliances, Rod 4 | Oral Osteodistraction, L.P. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K972047 | KLS-Martin Rigid External Distraction DeviceSummary page 1…tion Name: External Maxillary Fixator and/or Distractor - MQN Predicate Device: KLS Martin Rigid External Distractor K972047 Oral Osteodistraction Rod Appliances (Rod 1,2,3) K014001 Intended Use: The Rod-4 Distraction dev… | 1997 |
| * | K014001 | Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Summary page 1…e: KLS Martin Rigid External Distractor K972047 Oral Osteodistraction Rod Appliances (Rod 1,2,3) K014001 Intended Use: The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconst… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
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-4 Distraction device is utilized for the purpose of maxillary and midface
Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial
anomalies, narrow and underdeveloped maxilla.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034045: Oral Osteodistraction Distraction Rod Appliances, Rod 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034045
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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