# K040851: Medpor Attractor Magnetic Coupling System

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Jul 16, 2004 after 107 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 K960859 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971583: Medpor Ocular Screw and Acceossories, Porex Technologies Corp. (1997) Summary page 1.
- K960859: Medpor Ocular Peg System and Accessories, Porex Technologies Corp. of Georgia (1996) Summary page 1.

## Indications for use
The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the ocular Implant to the prosthetic eye. NOTE: Improved prosthesis motility is a function of adequate Implant motility, adequate coupling forces between the Implant and the prosthesis, and adequate room in the socket for prosthesis motility. Not all patients will benefit from the use of the MEDPOR Attractor Magnetic Coupling System. Consider all factors affecting potential prosthesis motility when selecting patients for the MEDPOR ATTRACTOR Magnetic Coupling System.

Source page: https://510kreport.com/device/K040851
Methodology: https://510kreport.com/methodology