# K053298: Alphasphere Orbital Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hydron Pty Limited
- Decided: May 9, 2006 after 165 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 K003338 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010902: Medpor Quad Motility Implant, Porex Surgical, Inc. (2001) Summary page 1.
- K003338: Bio-Eye II Orbital Implant, Integrated Orbital Implants, Inc. (2001) Summary page 1.
- K013756: Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes), Argus Biomedical Pty, Ltd. (2002) Summary page 1.

## Indications for use
The AlphaSphere Orbital Implant is intended to replace orbital volume after loss of an eye through enucleation or evisceration, including secondary implantation after removal of an existing, unsatisfactory, orbital implant. The device is indicated in any situation where silicone, acrylic, polyethylene, coral, glass, or other traditional orbital implants are used.

Source page: https://510kreport.com/device/K053298
Methodology: https://510kreport.com/methodology