# K112176: Silicone Spheres

- Pathway: 510(k) (Special)
- Applicant: Oculo Plastik, Inc.
- Decided: Sep 15, 2011 after 49 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: 1 generation back to K040689 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040689: Eye Sphere Implants, Oculo Plastik, Inc. (2004) Summary page 1.

## Indications for use
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/K112176
Methodology: https://510kreport.com/methodology