# K071214: Ats Simulus Adjustable Flexible Annuloplasty Ring

- Pathway: 510(k) (Special)
- Applicant: Genesee Biomedical, Inc.
- Decided: Jul 31, 2007 after 91 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). 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)
- K052565: Ats Simulus Annuloplasty Ring, Model 700FF, Genesee Biomedical, Inc. (2005) Summary page 1.
- K905175: Pti Annuloplasty Ring (Sterile), Pioneering Technologies, Inc. (1992) Summary page 1.
- K801879: Puig Massana-Shiley Annuloplasty Ring, Shiley, Inc. (1980). Our reading of the summary gave K801876, FDA’s number for Strep B Polyvalent Fluoro-Kit (Clinical Sciences, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Puig Massana-Shiley Annuloplasty Ring”.

## Cited in the summary but kept off the family tree
- K821258: Selopor, Selomas, Inc. (1982). Our reading of the summary gave K821258, FDA’s number for Selopor (Selomas, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Puig Massana-Shiley Annuloplasty Ring”. Kept off the family tree. Summary page 1.

## Indications for use
The ATS SIMULUS Adjustable Flexible Annuloplasty Rings Model 735AF are for use in those patients undergoing surgery of diseased or damaged mitral or 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 mitral or tricuspid annulus and restrict expansion of the annulus

Source page: https://510kreport.com/device/K071214
Methodology: https://510kreport.com/methodology