510(k) · Cleared
ClearedZurich Titanium Ossicular Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · ETA Replacement, Ossicular Prosthesis, Total
Cleared on Nov 10, 1999 after a 19-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 10, 1999
- Review
- 19 days
- Class
- Class II
- Product code
- ETA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993583 Zurich Titanium Ossicular Replacement SystemStryker Corp. · 1999
- Descendant · cites it directly · 0 of its ownK043375 Fisch Titanium Middle Ear ProsthesesKarl Storz Endoscopy · 2005
Most influential descendants
Showing 1 of 1 · See all- K043375Fisch Titanium Middle Ear ProsthesesKarl Storz Endoscopy · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993583 | Zurich Titanium Ossicular Replacement System | Stryker Corp. | 1999 | — |
| +1 | K043375 | Fisch Titanium Middle Ear Prostheses | Karl Storz Endoscopy | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ETA device
- #1 K241269 mXACT Total Prosthesis Offcenter, mXACT Total…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Micromedics S&T Total Ossicular Replacement Prosthesis Named without a submission number | |
| * | — | Tübingen Titanium Prosthesis (TTP) Vario Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043375 | Fisch Titanium Middle Ear Prostheses | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043375 (Karl Storz Endoscopy, 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ETA devicesETA Replacement, Ossicular Prosthesis, Total: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETA
Too few ETA 510(k)s in any year since 2007 to give a median.
Recalls per year · ETA
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETA
4in 2025
MAUDE reports naming product code ETA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (190 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993583: Zurich Titanium Ossicular Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993583
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026