# K030492: Titanium Ossicular Replacment System

- Pathway: 510(k) (Traditional)
- Applicant: Invotec International, Inc.
- Decided: Mar 3, 2003 after 12 days
- Product code: ETA (Replacement, Ossicular Prosthesis, Total)
- Device class: 2
- Regulation: 21 CFR 874.3495
- 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
Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.

Source page: https://510kreport.com/device/K030492
Methodology: https://510kreport.com/methodology