# K971583: Medpor Ocular Screw and Acceossories

- Pathway: 510(k) (Traditional)
- Applicant: Porex Technologies Corp.
- Decided: Jun 30, 1997 after 61 days
- Product code: MQU (Ocular Peg)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) Ocular Screw and Accessories: named in the summary without a submission number

## Most influential descendants
- K040851: Medpor Attractor Magnetic Coupling System (2004), 0 descendants of its own
- K974203: Perry-Kolberg (PK) Titanium Motility/Support System (1998), 0 descendants of its own

## Indications for use
The MCP® is indicated for patients with MEDPOR® Ocular Implants, who desire improved prosthetic eye motility via direct coupling of the implant to the prosthetic eye. Primary placement of the MCP® may occur during the initial reconstruction procedure, following attachment of the extraocular muscles to the ocular implant but before closing the Tenon’s capsule and the conjunctiva layer. Secondary placement of the MCP may occur typically 3-6 months post enucleation after the ocular implant has become vascularized. Please read additional instructions below.

Source page: https://510kreport.com/device/K971583
Methodology: https://510kreport.com/methodology