# K241253: Medicon Epiplating System

- Pathway: 510(k) (Traditional)
- Applicant: Cmf Medicon Surgical, Inc.
- Decided: Dec 12, 2024 after 223 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945154 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161548: Osseointegrated Fixtures, Southern Implants (Pty), Ltd. (2016) Summary page 5.

## Indications for use
The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

Source page: https://510kreport.com/device/K241253
Methodology: https://510kreport.com/methodology