# K230679: WellsForm Tricuspid Annuloplasty Band (WF)

- Pathway: 510(k) (Traditional)
- Applicant: Genesee Biomedical, Inc.
- Decided: May 26, 2023 after 74 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: 3 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)
- K093903: Ats Tri-AD Semi-Flexible Tricuspid Anuuloplasty, Model 900SFC, Genesee Biomedical, Inc. (2010) Summary page 4.

## Indications for use
WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

Source page: https://510kreport.com/device/K230679
Methodology: https://510kreport.com/methodology