# K993234: Micromedics S&T Partial Ossicular Replacement Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Nov 10, 1999 after 44 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For surgxcal reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.

Source page: https://510kreport.com/device/K993234
Methodology: https://510kreport.com/methodology