# K982562: Bio-Eye Hydroxyapatite Ocular Impland and Conformer

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Orbital Implants, Inc.
- Decided: Dec 28, 1998 after 158 days
- Product code: HPZ (Implant, Eye Sphere)
- Device class: 2
- Regulation: 21 CFR 886.3320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860983 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891137: Motility Orbital Implant, Integrated Orbital Implants, Inc. (1989) Summary page 1.
- K945110: Kolberg Ophthalmic Conformer, Kolberg Ocular Products, Inc. (1995) Summary page 1.
- K860983: Interpore 200 Porous Hydroxyapatite, Interpore Intl. (1986) Summary page 1.

## Most influential descendants
- K021643: HA Orbital Implant (2002), 0 descendants of its own

## Recalls of this device
- Jun 7, 2010 · Not classified · Z-2292-2010: Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was om
- Feb 27, 2006 · Not classified · Z-0012-2007: The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract p

## Indications for use
The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used. The Conformer is indicated in all cases in which an orbital implant is used.

Source page: https://510kreport.com/device/K982562
Methodology: https://510kreport.com/methodology