# K232350: Stryker Facial iD System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Craniomaxillofacial
- Decided: Jan 13, 2024 after 159 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: 7 generations back to K954385 (1996). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210731: KLS Martin Individual Patient Solutions, KLS-Martin L.P. (2022) Summary page 5.

## Indications for use
The Stryker Facial iD 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: - Orbital reconstructive/ trauma surgery

Source page: https://510kreport.com/device/K232350
Methodology: https://510kreport.com/methodology