# K042734: SJM Rigid Saddle Ring Model Rsar-(Size)

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: Dec 17, 2004 after 77 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: 3 generations back to K923367 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032250: Geoform Annuloplasty Ring, Mitral Model 4200, Edwards Lifesciences, LLC (2003) Summary page 1.
- (no number) Carpentier-McCarthy-Adams IMR-Etiologix annuloplasty ring model 4100: named in the summary without a submission number

## Indications for use
The SJMT M Rigid Saddle ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For mitral insufficiencies with no subvalvular lesions and normal valvular movements, prosthetic ring implant along may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commisures or chordae tendineae, or chordal hypertrophy.

Source page: https://510kreport.com/device/K042734
Methodology: https://510kreport.com/methodology