# K083470: Carpentier- Edwards Physio II Annuloplasty, Model 5200

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 23, 2009 after 60 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 K926138 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926138: Carpentier-Edwards Physio Annuloplasty Ring, Baxter Healthcare Corp (1993) Summary page 1.

## Most influential descendants
- K192762: Physio Flex Annuloplasty Ring (2019), 0 descendants of its own

## Indications for use
The Carpentier-Edwards Physio IIAnnuloplasty Ring is intended for the correction of mitral valve insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve The Carpentier-Edwards Physio IIAnnuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole The decision to undertake annuloplasty can be made only after visual analysis of the lesion present The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae The remodeling annuloplasty technique with a Carpentier-Edwards Physio IIAnnuloplasty Ring, Model 5200, may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue 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 IIinsufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy

Source page: https://510kreport.com/device/K083470
Methodology: https://510kreport.com/methodology