# K994154: Mod Line of Molina Distractors, 51-600 Series

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Feb 15, 2000 after 68 days
- Product code: JEY (Plate, Bone)
- 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: 1 generation back to K945500 (1995). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945500: Wells Johnson Fixation System, Wells Johnson Co. (1995) Summary page 1.

## Most influential descendants
- K034027: KLS Martin 3DX External Distraction System (2004), 3 descendants of its own
- K063792: Osteomed External Mandibular Distraction System (2007), 2 descendants of its own
- K062851: Osteomed Pediatric Intraoral Mandibular Distraction System, Extended (2006), 2 descendants of its own
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant of its own
- K123885: Osteomed Smartflex Cranial Spring Distractor (2013), 1 descendant of its own

## Indications for use
The KLS-Martin Molina Distractors are intended for use as external distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external pins.

Source page: https://510kreport.com/device/K994154
Methodology: https://510kreport.com/methodology