# K003883: Molina Orbital Malar Distractor

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jan 23, 2001 after 39 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
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 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
- K092743: The Leibinger Advance Internal Midface Distraction System (2010), 3 descendants of its own
- K121304: Osteomed Cranial Distraction System (2012), 2 descendants of its own
- K161470: Internal Distraction - Sterile (2016), 1 descendant 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

Source page: https://510kreport.com/device/K003883
Methodology: https://510kreport.com/methodology