# K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 17, 2002 after 30 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 K923367 (1993). 1 ancestor in all.
10 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600, Baxter Healthcare Corp (1993) Summary page 1.

## Most influential descendants
- K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring (2011), 3 descendants of its own
- K032250: Geoform Annuloplasty Ring, Mitral Model 4200 (2003), 3 descendants of its own
- K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (2017), 1 descendant of its own
- K260498: TriMemo™ SEMIRIGID ANNULOPLASTY RING (2026), 0 descendants of its own
- K251982: Edwards MC3 Tricuspid annuloplasty ring (4900) (2025), 0 descendants of its own

## Indications for use
The Edwards® MC® Tricuspid Annuloplasty System is intended for use in patients to correct annular dilatation, increase leaftet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

Source page: https://510kreport.com/device/K020864
Methodology: https://510kreport.com/methodology