# K212741: Ezypor

- Pathway: 510(k) (Traditional)
- Applicant: Fci (France Chirurgie Instrumentation) Sas
- Decided: Jun 24, 2022 after 298 days
- Product code: HPZ (Implant, Eye Sphere)
- Device class: 2
- Regulation: 21 CFR 886.3320
- 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 K021357 (2002). 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)
- K021357: Medpor Plus Orbital Volume Replacement Impant, Porex Surgical, Inc. (2002) Summary page 4.

## Indications for use
The EZYPOR@ orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.

Source page: https://510kreport.com/device/K212741
Methodology: https://510kreport.com/methodology