# K003214: Smith & Nephew Pistons

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Oct 31, 2000 after 18 days
- Product code: ETB (Prosthesis, Partial Ossicular Replacement)
- Device class: 2
- Regulation: 21 CFR 874.3450
- Recalls of this device: 2 (0 Class I)
- 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; 3 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Jul 14, 2020 · Class II · Z-2814-2020: Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
- Jul 14, 2020 · Class II · Z-2813-2020: Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

Source page: https://510kreport.com/device/K003214
Methodology: https://510kreport.com/methodology