# K972735: Total Ossicular Replacement Prosthesis (Torp)

- Pathway: 510(k) (Traditional)
- Applicant: Mednet Locator, Inc.
- Decided: Sep 5, 1997 after 45 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K972735
Methodology: https://510kreport.com/methodology