# K161470: Internal Distraction - Sterile

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Dec 1, 2016 after 188 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
Longest line of descent: 4 generations back to K792561 (1979). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 4.
- K973275: KLS-Martin Intraoral Distractor, KLS-Martin L.P. (1997) Summary page 4.
- K983515: KLS Intraoral Vertical Distractor, KLS-Martin L.P. (1998) Summary page 4.
- K983809: KLS Martin Intraoral Zurich Ramus Distractor, KLS-Martin L.P. (1999) Summary page 4.
- K991875: K-L-W Intraoral Distractor, KLS-Martin L.P. (1999) Summary page 4.
- K000580: Zurich Pediatric Maxillary Distractor, Models 51-550-15 and 51-551-15, KLS-Martin L.P. (2000) Summary page 4.
- K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction, KLS-Martin L.P. (2000) Summary page 4.
- K003883: Molina Orbital Malar Distractor, KLS-Martin L.P. (2001) Summary page 4.

## Most influential descendants
- K220050: KLS Martin IPS Distraction (2022), 0 descendants of its own

## Indications for use
Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis) and mid-face bones that require gradual distraction.

Source page: https://510kreport.com/device/K161470
Methodology: https://510kreport.com/methodology