# K033554: Smart Offset Stapes Piston; Smart Isj Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Nov 24, 2003 after 12 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.
7 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Angular Piston: named in the summary without a submission number
- (no number) Angular Prosthesis (Plester): named in the summary without a submission number

## Most influential descendants
- K063374: Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe (2006), 4 descendants of its own
- K112616: Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis (2013), 3 descendants of its own
- K130512: Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis (2013), 2 descendants of its own
- K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (2025), 1 descendant of its own
- K080070: K-Helix Piston and Porp Partial Ossicular Replacement Prostheses (2008), 1 descendant of its own

## Indications for use
Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition. Bridging defects at the long incudal process with otherwise intact mobile chain.

Source page: https://510kreport.com/device/K033554
Methodology: https://510kreport.com/methodology