# K193136: Stryker Customized Mandible Recon Plate Kit

- 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: 6 generations back to K904111 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132519: Stryker Customized Mandible Recon Plate Kit, Stryker (2013) Summary page 4.

## Most influential descendants
- K222650: Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (2022), 0 descendants of its own

## Indications for use
The Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.

Source page: https://510kreport.com/device/K193136
Methodology: https://510kreport.com/methodology