# K093903: Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC

- Pathway: 510(k) (Special)
- Applicant: Genesee Biomedical, Inc.
- Decided: Jul 15, 2010 after 205 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 K905175 (1992). 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)
- K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR, Genesee Biomedical, Inc. (2007) Summary page 1.

## Most influential descendants
- K230679: WellsForm Tricuspid Annuloplasty Band (WF) (2023), 0 descendants of its own

## Indications for use
The ATS TRI-ADTM Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for use in those patients undergoing surgery of diseased or damaged tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty Rings provide support for the tricuspid annulus and restrict expansion of the annulus.

Source page: https://510kreport.com/device/K093903
Methodology: https://510kreport.com/methodology