# K980822: Titanium Peg System

- Pathway: 510(k) (Traditional)
- Applicant: Fci Ophthalmics, Inc.
- Decided: Jul 9, 1998 after 128 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.

Source page: https://510kreport.com/device/K980822
Methodology: https://510kreport.com/methodology