# K993583: Zurich Titanium Ossicular Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Nov 10, 1999 after 19 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Micromedics S&T Total Ossicular Replacement Prosthesis: named in the summary without a submission number
- (no number) Tübingen Titanium Prosthesis (TTP) Vario: named in the summary without a submission number

## Most influential descendants
- K043375: Fisch Titanium Middle Ear Prostheses (2005), 0 descendants of its own

## Indications for use
The Leibinger titanium ossicular chain reconstruction prostheses and accessories are used 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. Titanium ossicular chain reconstruction prostheses are available for the following indications: Chronic otitis media Immobility of the stapes (otosclerosis in particular) Injury of the ossicle (trauma) Abnormal and defective formation of the middle ear Secondary procedure to improve hearing Revision operation on a malpositioned prosthesis Product Designation — Product Intended Use Stapes prosthesis — Flat band and piston prosthesis for attachment to the malleus or incus, inserted through the footplate of the stapes. Total prosthesis (TORP) — Plate prosthesis with shaft and shoe as ossicle replacement between the tympanic membrane and the footplate of the stapes. Neomalleus total prosthesis — Malleus prosthesis as ossicle replacement in combination with stapes prosthesis. Incus prosthesis — Incus replacement to connect malleus and head of stapes. Partial prosthesis (PORP) — Malleus and incus replacement to connect tympanic membrane and head of stapes.

Source page: https://510kreport.com/device/K993583
Methodology: https://510kreport.com/methodology