# K230398: MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Medcad
- Decided: Sep 26, 2023 after 222 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 K954385 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191028: KLS Martin Individual Patient Solutions, KLS-Martin L.P. (2019) Summary page 5.

## Indications for use
The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.

Source page: https://510kreport.com/device/K230398
Methodology: https://510kreport.com/methodology