# K230318: Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Corcym S.r.l.
- Decided: Apr 7, 2023 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: 4 generations back to K926138 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071327: Memo 3D Semirigid Annuloplasty Ring, Sorin Biomedica Cardio S.R.L. (2007) Summary page 4.
- K142221: MEMO 3D ReChord, Sorin Group Italia S.R.L. (2014) Summary page 4.
- K180411: MEMO 4D, Sorin Group Italia S.R.L. (2018) Summary page 4.

## Most influential descendants
- K261707: MEMO 4D Curve™ Semirigid mitral annuloplasty ring (2026), 0 descendants of its own

## Indications for use
Memo 3D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty. The use of the MEMO 3D ReChord device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty. The use of the Memo 4D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficient with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Source page: https://510kreport.com/device/K230318
Methodology: https://510kreport.com/methodology