# K992294: Bioceramic Orbital Implant

- Pathway: 510(k) (Traditional)
- Applicant: Fci Ophthalmics, Inc.
- Decided: Apr 19, 2000 after 287 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
As a primary implant for patients who present with eye disease or severe damage such that the eye must be enucleated or eviscerated. An existing orbital implant that is malfunctioning or not satisfying the patient in terms of performance, may call for a secondary implant procedure to install a bio-ceramic orbital implant.

Source page: https://510kreport.com/device/K992294
Methodology: https://510kreport.com/methodology