# K972143: Moa Bone / M-Sphere

- Pathway: 510(k) (Traditional)
- Applicant: Iop, Inc.
- Decided: Oct 16, 1997 after 132 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
Hydroxyapitate orbital implants are indicated for post enucleation patients. This product is intended to establish a platform to affix an artificial eye that becomes integrated with the patients tissues.

Source page: https://510kreport.com/device/K972143
Methodology: https://510kreport.com/methodology