# K132519: Stryker Customized Mandible Recon Plate Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Dec 6, 2013 after 116 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: 5 generations back to K904111 (1990). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014263: Newgen/Universal Mandibular System, Stryker Instruments (2002) Summary page 1.
- K122647: Synthes Patient Specific Plate, Synthes, Inc. (2013) Summary page 1.
- K121153: Peek Customized Craial Implant Kit, Stryker (2012) Summary page 1.

## Most influential descendants
- K193136: Stryker Customized Mandible Recon Plate Kit (2020), 1 descendant of its own
- K222650: Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (2022), 0 descendants of its own
- K190696: Stryker Surgeon iD Mandible Recon Plate (2019), 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/K132519
Methodology: https://510kreport.com/methodology