# K073324: Medtronic Profile 3D Annuloplasty Ring, Model 680R

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Mar 13, 2008 after 107 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: 4 generations back to K893678 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061127: CG Future Annuloplasty System, Model 638R, Medtronic Vascular (2006) Summary page 1.

## Indications for use
The PROFILE 3D Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Source page: https://510kreport.com/device/K073324
Methodology: https://510kreport.com/methodology