# K083342: Orbital Reconstructive Implant II

- Pathway: 510(k) (Traditional)
- Applicant: Evera Medical, Inc.
- Decided: Mar 12, 2009 after 120 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: 3 generations back to K921106 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070130: Orbital Reconstructive Implant, Becker & Associates Consulting, Inc. (2007) Summary page 1.
- K021357: Medpor Plus Orbital Volume Replacement Impant, Porex Surgical, Inc. (2002) Summary page 1.
- K934834: Eptfe Sheet Covering for Ocular Implant, Oculo Plastik, Inc. (1994) Summary page 1.
- K950806: Solid Dilicone Implants, Sdilicone Sponge Implants, Mira, Inc. (1996) Summary page 2.

## Indications for use
The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.

Source page: https://510kreport.com/device/K083342
Methodology: https://510kreport.com/methodology