# K060518: Partial Ossicular Replacement Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Jun 28, 2006 after 121 days
- Product code: ETB (Prosthesis, Partial Ossicular Replacement)
- Device class: 2
- Regulation: 21 CFR 874.3450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991394 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991394: Stapes Prostheses, Grace Medical, Inc. (1999) Summary page 2.
- (no number) Partial Ossicular Replacement Prostheses marketed by Gyrus ENT LLC: named in the summary without a submission number

## Recalls of this device
- Apr 3, 2026 · Class II · Z-2308-2026: Due to incorrect functional length on device labeling.

## Indications for use
A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis, (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

Source page: https://510kreport.com/device/K060518
Methodology: https://510kreport.com/methodology