# K021643: HA Orbital Implant

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoire Villanova
- Decided: Dec 13, 2002 after 207 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: 2 generations back to K860983 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982562: Bio-Eye Hydroxyapatite Ocular Impland and Conformer, Integrated Orbital Implants, Inc. (1998) Summary page 1.

## Indications for use
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Calo(PO₄) (OH)₂) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

Source page: https://510kreport.com/device/K021643
Methodology: https://510kreport.com/methodology