# K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR

- Pathway: 510(k) (Special)
- Applicant: Genesee Biomedical, Inc.
- Decided: Oct 23, 2007 after 33 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 K905175 (1992). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905175: Pti Annuloplasty Ring (Sterile), Pioneering Technologies, Inc. (1992) Summary page 1.

## Most influential descendants
- K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF) (2024), 1 descendant of its own
- K093903: Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC (2010), 1 descendant of its own
- K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF) (2025), 0 descendants of its own
- K230679: WellsForm Tricuspid Annuloplasty Band (WF) (2023), 0 descendants of its own
- K201449: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (2020), 0 descendants of its own

## Indications for use
The ATS SIMULUSTM Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral 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 mitral annulus and restrict expansion of the annulus.

Source page: https://510kreport.com/device/K072655
Methodology: https://510kreport.com/methodology