# K122647: Synthes Patient Specific Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes, Inc.
- Decided: Feb 28, 2013 after 182 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: 1 generation back to K063790 (2007). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063790: The Synthes Matrixmandible Plate and Screw System, Synthes (Usa) (2007) Summary page 1.
- K091144: Synthes Matrixmandible Preformed Reconstruction Plates, Synthes (Usa) (2009) Summary page 1.

## Most influential descendants
- K132519: Stryker Customized Mandible Recon Plate Kit (2013), 3 descendants of its own
- 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
- K193280: MedCAD® AccuPlate® Patient-Specific Plate (2021), 0 descendants of its own
- K190696: Stryker Surgeon iD Mandible Recon Plate (2019), 0 descendants of its own

## Indications for use
Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. Specific Indications for Use: Primary mandibular reconstruction with bone graft Temporary bridging until delayed secondary reconstruction Secondary mandibular reconstruction Comminuted mandibular fractures Fractures of edentulous and/or atrophic mandibles Unstable mandibular fractures Maxillary reconstruction with or without bone graft Maxillary trauma

Source page: https://510kreport.com/device/K122647
Methodology: https://510kreport.com/methodology