510(k) · Cleared
ClearedFisch Titanium Middle Ear Prostheses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy · ETA Replacement, Ossicular Prosthesis, Total
Cleared on Jan 24, 2005 as substantially equivalent to K993583 (Stryker Corp., 1999) after a 47-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jan 24, 2005
- Review
- 47 days
- Class
- Class II
- Product code
- ETA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993583 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993583 Zurich Titanium Ossicular Replacement SystemStryker Corp. · 1999
- This deviceK043375 Fisch Titanium Middle Ear ProsthesesKarl Storz Endoscopy · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993583 | Zurich Titanium Ossicular Replacement System | Stryker Corp. | 1999 | — |
| 0 (this device) | K043375 | Fisch Titanium Middle Ear Prostheses | Karl Storz Endoscopy | 2005 | — |
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? (1)
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 |
|---|---|---|---|
| * | K993583 | Zurich Titanium Ossicular Replacement SystemSummary page 2…ium Stapes Prosthesis DEVICE STRYKER/ LEIBINGER - FISCH KARL STORZ - FISCH TITANIUM TITANIUM STAPES PISTON (K993583) STAPES PISTON 1.INTENDED USE Flat band and piston prosthesis for Same… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043375: Fisch Titanium Middle Ear Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043375
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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