510(k) · Cleared
ClearedTotal Ossicular Replacement Prosthesis (Torp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mednet Locator, Inc. · ETA Replacement, Ossicular Prosthesis, Total
Cleared on Sep 5, 1997 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 5, 1997
- Review
- 45 days
- Class
- Class II
- Product code
- ETA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 MedNef Locator, Inc., Total Ossicular Replacement Prosthesis
(TORP) is to be used by ear, nose and throat physicians to restore the
hearing mechanism related to loss or destruction or damage to the ear
ossicles due to prolonged chronic infection.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972735: Total Ossicular Replacement Prosthesis (Torp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972735
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026