# K193280: MedCAD® AccuPlate® Patient-Specific Plate

- Pathway: 510(k) (Traditional)
- Applicant: Medcad
- Decided: Feb 12, 2021 after 443 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: 2 generations back to K063790 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122647: Synthes Patient Specific Plate, Synthes, Inc. (2013) Summary page 4.

## Indications for use
The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription 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/K193280
Methodology: https://510kreport.com/methodology