# K080070: K-Helix Piston and Porp Partial Ossicular Replacement Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Apr 17, 2008 after 98 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
Longest line of descent: 3 generations back to K002221 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033554: Smart Offset Stapes Piston; Smart Isj Prosthesis, Gyrus Ent LLC (2003) Summary page 1.
- K003214: Smith & Nephew Pistons, Gyrus Ent LLC (2000) Summary page 1.
- K972492: Bell Prosthesis (Partial), Heinz Kurz (1997) Summary page 1.
- K042503: Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM, Heinz Kurz GmbH Medizintechnik (2004) Summary page 1.

## Most influential descendants
- K091187: Grace Dynamic Torp (2009), 0 descendants of its own

## 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/K080070
Methodology: https://510kreport.com/methodology