# K043375: Fisch Titanium Middle Ear Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Jan 24, 2005 after 47 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
Longest line of descent: 1 generation back to K993583 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993583: Zurich Titanium Ossicular Replacement System, Stryker Corp. (1999) Summary page 2.

## Indications for use
The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.

Source page: https://510kreport.com/device/K043375
Methodology: https://510kreport.com/methodology