# K070130: Orbital Reconstructive Implant

- Pathway: 510(k) (Traditional)
- Applicant: Becker & Associates Consulting, Inc.
- Decided: Apr 19, 2007 after 93 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: 2 generations back to K921106 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021357: Medpor Plus Orbital Volume Replacement Impant, Porex Surgical, Inc. (2002) Summary page 1.
- K972661: Eye Sphere, Conformers, Gulden Ophthalmics (1997) Summary page 1.
- K060151: Orbital Tissue Expander (Ote), Innovia, LLC (2006) Summary page 2.
- K934834: Eptfe Sheet Covering for Ocular Implant, Oculo Plastik, Inc. (1994) Summary page 2.

## Most influential descendants
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own

## Indications for use
The Orbital Reconstructive Implant 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. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.

Source page: https://510kreport.com/device/K070130
Methodology: https://510kreport.com/methodology