# K962241: Gore Spherex Implant

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Aug 22, 1996 after 72 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.
No later device cites it as a predicate yet.
0 of 1 device 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) SAM Reinforced Facial Implant: named in the summary without a submission number
- (no number) Porex MEDPOR Biomaterial, Conical Volume Augmentation (CVA) Implant: named in the summary without a submission number
- (no number) Porex MEDPOR Biomaterial, Preformed Craniofacial Implant: named in the summary without a submission number

## Indications for use
The GORE Spherex Implant is intended to be used as a corrective prosthesis for the anophthalmic socket.

Source page: https://510kreport.com/device/K962241
Methodology: https://510kreport.com/methodology