# K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Oct 10, 2000 after 85 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K161470: Internal Distraction - Sterile (2016), 1 descendant of its own
- K042278: Oral Osteodistraction Rod Appliance (Rod 5) (2005), 1 descendant of its own
- K220050: KLS Martin IPS Distraction (2022), 0 descendants of its own
- K080458: Mis Crest Widener (2008), 0 descendants of its own
- K030790: Osteomed Alveolar Distraction System (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K002152
Methodology: https://510kreport.com/methodology