# K973356: K-Piston with Band Hook /Angular Piston

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz
- Decided: Nov 21, 1997 after 74 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. The FDA summary names its predicate without a number.
- (no number) FDA-approved devices manufactured by Smith & Nephew Richards: named in the summary without a submission number
- (no number) FDA-approved devices manufactured by XOMED (which also markets TREACE devices): named in the summary without a submission number

## Indications for use
For bridging the stapes in case of otosclerosis, also for bridging defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy). For bridging the stapes of otosclerosis, specifically for surgical revisions in patients with shortenend incudal process and for primary procedures when this anatomical condition is present.

Source page: https://510kreport.com/device/K973356
Methodology: https://510kreport.com/methodology