# K071327: Memo 3D Semirigid Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedica Cardio S.R.L.
- Decided: Aug 10, 2007 after 91 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: 1 generation back to K926138 (1993). 4 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K926138: Carpentier-Edwards Physio Annuloplasty Ring, Baxter Healthcare Corp (1993) Summary page 1.
- K970375: Annuloflo System, Carbomedics, Inc. (1997) Summary page 1.
- K021051: Annuloflo System, Mitral Model AR700, Sulzer Carbomedics, Inc. (2002) Summary page 1.
- K023185: Annuloflex Annuoplasty System, Model AF 800, Sulzer Carbomedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K142221: MEMO 3D ReChord (2014), 3 descendants of its own
- K180411: MEMO 4D (2018), 2 descendants of its own
- K230318: Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (2023), 1 descendant of its own
- K261707: MEMO 4D Curve™ Semirigid mitral annuloplasty ring (2026), 0 descendants of its own

## Indications for use
MEMO 3DTM device is intended for correction of mitral insufficiencies or sten- insufficiencies. The use of the MEMO 3DTM device is indicated for correction of congenital or acquired mitral 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 device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized 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/K071327
Methodology: https://510kreport.com/methodology