# K031761: Synthes (Usa) New/Sterial Orbital Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 3, 2003 after 89 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Maxillofacial Titanium Micro Set: named in the summary without a submission number
- (no number) Synthes Orbital Mesh Plates: named in the summary without a submission number

## Most influential descendants
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K180249: OmniPore DUROMAX Surgical Implants (2018), 0 descendants of its own
- K140978: Osteomed Low Profile Orbital Floor Plate System (2014), 0 descendants of its own

## Indications for use
The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K031761
Methodology: https://510kreport.com/methodology