# K193143: Stryker Facial iD Plating System

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Mar 26, 2020 after 134 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: 3 generations back to K063790 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182305: Stryker Facial iD Plating System, Stryker (2019) Summary page 4.

## Indications for use
The Stryker Facial iD Plating System is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher). Specific Indications for Use: -Orthognathic surgery -Reconstructive maxillofacial surgery -Mandible and maxillofacial trauma surgery.

Source page: https://510kreport.com/device/K193143
Methodology: https://510kreport.com/methodology
