# K991394: Stapes Prostheses

- Pathway: 510(k) (Special)
- Applicant: Grace Medical, Inc.
- Decided: May 18, 1999 after 27 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K060518: Partial Ossicular Replacement Prostheses (2006), 0 descendants of its own

## Indications for use
Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications include: Chronic middle ear disease Otosclerosis Congenital fixation of the stapes Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery Surgically correctible injury to the middle ear from trauma

Source page: https://510kreport.com/device/K991394
Methodology: https://510kreport.com/methodology