# K010499: Synthes (Usa) Midface Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 3, 2001 after 71 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

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

## Recalls of this device
- Jan 11, 2013 · Class II · Z-0942-2013: There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.

Source page: https://510kreport.com/device/K010499
Methodology: https://510kreport.com/methodology