# K032250: Geoform Annuloplasty Ring, Mitral Model 4200

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 26, 2003 after 35 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: 2 generations back to K923367 (1993). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831949: Prosthetic Rings #4400 Mitral & 4500, American Edwards Laboratories (1983) Summary page 1.
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600, Baxter Healthcare Corp (1993) Summary page 1.
- K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900, Edwards Lifesciences, LLC (2002) Summary page 1.

## Most influential descendants
- K083623: Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 (2009), 0 descendants of its own
- K083191: Detlogix Annuloplasty Ring, Model: 5100 (2009), 0 descendants of its own
- K042734: SJM Rigid Saddle Ring Model Rsar-(Size) (2004), 0 descendants of its own

## Indications for use
The Edwards03 GeoFormTh*Annuloplasty Ring is indicated for the correction of mitral valve insufficiency where the lesions are not so severe as to require total valve replacement. The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendineae. The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus. For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

Source page: https://510kreport.com/device/K032250
Methodology: https://510kreport.com/methodology