# K040689: Eye Sphere Implants

- Pathway: 510(k) (Traditional)
- Applicant: Oculo Plastik, Inc.
- Decided: Jun 10, 2004 after 86 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K112176: Silicone Spheres (2011), 0 descendants of its own

## Indications for use
Acrylic (PMMA) or Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or the space left after the removal of another ocular Implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

Source page: https://510kreport.com/device/K040689
Methodology: https://510kreport.com/methodology