# K201449: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 1, 2020 after 30 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 5.
- K052899: Ats Simulus Annuloplasty Band, Model 700FC, Genesee Biomedical, Inc. (2005) Summary page 5.
- K072655: Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR, Genesee Biomedical, Inc. (2007) Summary page 5.

## Indications for use
The SimuPlus flexible annuloplasty ring and band are indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimuPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus. The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.

Source page: https://510kreport.com/device/K201449
Methodology: https://510kreport.com/methodology