# K043297: Medicon 2.4 Mandibular Reconstruction Plating System

- Pathway: 510(k) (Special)
- Applicant: Medicon EG
- Decided: Feb 23, 2005 after 86 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 K951689 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951689: Titanium Mandibulat Reconstruction System, Medicon EG (1995) Summary page 2.

## Indications for use
The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.

Source page: https://510kreport.com/device/K043297
Methodology: https://510kreport.com/methodology