# K083835: Attune Adjustable Flexible Annuloplasty Ring Model Afr

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jan 23, 2009 after 31 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 K000119 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014161: SJM Tailor Annuloplasty Ring Model Tarp- (Size), St. Jude Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K092876: SJM Attune Annuloplasty Ring (2009), 0 descendants of its own

## Indications for use
The Attune™ Adjustable Flexible Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the Attune™ Adjustable Flexible Annuloplasty Ring

Source page: https://510kreport.com/device/K083835
Methodology: https://510kreport.com/methodology