# K020505: Synthes Translating Maxillary Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 23, 2002 after 67 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate.

## Most influential descendants
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Synthes Translating Maxillary Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.

Source page: https://510kreport.com/device/K020505
Methodology: https://510kreport.com/methodology