# K023185: Annuloflex Annuoplasty System, Model AF 800

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Carbomedics, Inc.
- Decided: Dec 17, 2002 after 84 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Sulzer Carbomedics AnnuloFlex Annuloplasty Ring: named in the summary without a submission number
- (no number) Medtronic Duran Flexible Ring: named in the summary without a submission number
- (no number) Baxter Cosgrove-Edwards Ring: named in the summary without a submission number

## Most influential descendants
- K071327: Memo 3D Semirigid Annuloplasty Ring (2007), 4 descendants of its own
- 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
The Sulzer Carbomedics AnnuloFlex Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Source page: https://510kreport.com/device/K023185
Methodology: https://510kreport.com/methodology