# K073293: Durette Implant

- Pathway: 510(k) (Traditional)
- Applicant: Oculo Plastik, Inc.
- Decided: Mar 19, 2008 after 117 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. The FDA summary names its predicate without a number.
- (no number) original Allen implant: named in the summary without a submission number
- (no number) Iowa implant: named in the summary without a submission number
- (no number) New Allen implant: named in the summary without a submission number
- (no number) Universal implant: named in the summary without a submission number
- (no number) acrylic sphere implants: named in the summary without a submission number

## Most influential descendants
- K123764: Durette Ocular Implant (2013), 0 descendants of its own

## 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/K073293
Methodology: https://510kreport.com/methodology