# K091187: Grace Dynamic Torp

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Sep 14, 2009 after 144 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
Longest line of descent: 4 generations back to K002221 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972585: Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen, Heinz Kurz GmbH Medizintechnik (1997) Summary page 1.
- K080070: K-Helix Piston and Porp Partial Ossicular Replacement Prostheses, Grace Medical, Inc. (2008) Summary page 1.
- K061853: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses, Grace Medical, Inc. (2006) Summary page 1.

## Indications for use
An 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/K091187
Methodology: https://510kreport.com/methodology