# K123764: Durette Ocular Implant

- Pathway: 510(k) (Traditional)
- Applicant: Oculo-Plastik, Inc.
- Decided: Jan 31, 2013 after 55 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 K073293 (2008). 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)
- K073293: Durette Implant, Oculo Plastik, Inc. (2008) Summary page 1.

## Indications for use
The Durette ocular acrylic (PMMA) implants in 4 models 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 space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

Source page: https://510kreport.com/device/K123764
Methodology: https://510kreport.com/methodology