# K034027: KLS Martin 3DX External Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Feb 27, 2004 after 60 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: 3 generations back to K864403 (1986). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994154: Mod Line of Molina Distractors, 51-600 Series, KLS-Martin L.P. (2000) Summary page 1.
- K960297: Mandibular Bone Distractor II, Howmedica Corp. (1996) Summary page 1.
- K981362: Synthes (Usa) External Multi Vector Mandible Distractor, Synthes (Usa) (1998) Summary page 1.
- K992873: Lorenz External Mandibular Distractor, Walter Lorenz Surgical, Inc. (1999) Summary page 1.

## Most influential descendants
- K063792: Osteomed External Mandibular Distraction System (2007), 2 descendants of its own
- K123885: Osteomed Smartflex Cranial Spring Distractor (2013), 1 descendant of its own
- K230211: CranioXpand (2023), 0 descendants of its own

## Indications for use
The KLS Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.

Source page: https://510kreport.com/device/K034027
Methodology: https://510kreport.com/methodology