510(k) · Cleared
ClearedTrack 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Oct 10, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 10, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK002152 Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus…KLS-Martin L.P. · 2000
- Descendant · cites it directly · 1 of its ownK161470 Internal Distraction - SterileKLS Martin L.P. · 2016
- Descendant · cites it directly · 1 of its ownK042278 Oral Osteodistraction Rod Appliance (Rod 5)Oral Osteodistraction, L.P. · 2005
- Descendant · 2 generations on · 0 of its ownK220050 KLS Martin IPS DistractionKLS Martin L.P. · 2022
- Descendant · cites it directly · 0 of its ownK080458 Mis Crest WidenerMis - Implant Technologies, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK030790 Osteomed Alveolar Distraction SystemOsteomed LP · 2003
Most influential descendants
Showing 5 of 5 · See all- K161470Internal Distraction - SterileKLS Martin L.P. · 2016 · cites it directly1descendant
- K042278Oral Osteodistraction Rod Appliance (Rod 5)Oral Osteodistraction, L.P. · 2005 · cites it directly1descendant
- K220050KLS Martin IPS DistractionKLS Martin L.P. · 2022 · 2 generations on0descendants
- K080458Mis Crest WidenerMis - Implant Technologies, Ltd. · 2008 · cites it directly0descendants
- K030790Osteomed Alveolar Distraction SystemOsteomed LP · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002152 | Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction | KLS-Martin L.P. | 2000 | — |
| +1 | K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016 | — |
| +1 | K042278 | Oral Osteodistraction Rod Appliance (Rod 5) | Oral Osteodistraction, L.P. | 2005 | — |
| +2 | K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022 | — |
| +1 | K080458 | Mis Crest Widener | Mis - Implant Technologies, Ltd. | 2008 | — |
| +1 | K030790 | Osteomed Alveolar Distraction System | Osteomed LP | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 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?
- Of its descendants, K161470 (KLS Martin L.P., 2016) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K002152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002152
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026