# K260498: TriMemo™ SEMIRIGID ANNULOPLASTY RING

- Pathway: 510(k) (Abbreviated)
- Applicant: Corcym S.r.l.
- Decided: Apr 14, 2026 after 60 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- 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 K923367 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring, Edwards Lifesciences, LLC (2011) Summary page 5.

## Indications for use
TriMemo is indicated for use in patients suffering from congenital or acquired tricuspid insufficiencies or steno-insufficiencies with dilatation and/or deformation of the tricuspid annulus.

Source page: https://510kreport.com/device/K260498
Methodology: https://510kreport.com/methodology
