# K092876: SJM Attune Annuloplasty Ring

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Oct 16, 2009 after 28 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 K000119 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083835: Attune Adjustable Flexible Annuloplasty Ring Model Afr, St Jude Medical (2009) Summary page 1.

## Indications for use
The SJMTM Attune 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.

Source page: https://510kreport.com/device/K092876
Methodology: https://510kreport.com/methodology