# K962564: Richards Total/Partial Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Jan 22, 1997 after 205 days
- Product code: ETB (Prosthesis, Partial Ossicular Replacement)
- Device class: 2
- Regulation: 21 CFR 874.3450
- 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. The FDA summary names its predicate without a number.
- (no number) Tilt-Top TORP: named in the summary without a submission number
- (no number) Tilt-Top PORP: named in the summary without a submission number

## Indications for use
total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect.

Source page: https://510kreport.com/device/K962564
Methodology: https://510kreport.com/methodology