# K083191: Detlogix Annuloplasty Ring, Model: 5100

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 10, 2009 after 163 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- K926138: Carpentier-Edwards Physio Annuloplasty Ring, Baxter Healthcare Corp (1993) Summary page 1.
- K831949: Prosthetic Rings #4400 Mitral & 4500, American Edwards Laboratories (1983) Summary page 1.

## Indications for use
The dETIogix annuloplasty ring, model 51 00, is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough 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/K083191
Methodology: https://510kreport.com/methodology