# K161815: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

- Pathway: 510(k) (Traditional)
- Applicant: Genesee Biomedical, Inc.
- Decided: Oct 12, 2016 after 103 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ATS Simulus Annuloplasty Ring Model 700FF: named in the summary without a submission number
- (no number) ATS Simulus FC Annuloplasty Ring Model 700FC: named in the summary without a submission number

## Most influential descendants
- K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF) (2024), 1 descendant of its own
- K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF) (2025), 0 descendants of its own

## Indications for use
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in 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 and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Source page: https://510kreport.com/device/K161815
Methodology: https://510kreport.com/methodology