# K222650: Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Craniomaxillofacial (Cmf)
- Decided: Dec 9, 2022 after 99 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 K904111 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193136: Stryker Customized Mandible Recon Plate Kit, Stryker (2020) Summary page 4.

## Indications for use
The Customized Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation. The Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation.

Source page: https://510kreport.com/device/K222650
Methodology: https://510kreport.com/methodology