# K220420: Saffron Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Jun 10, 2022 after 116 days
- Product code: PBQ (Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K042603 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120831: Anchorsure, Neomedic International S.L. (2012) Summary page 4.

## Indications for use
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.

Source page: https://510kreport.com/device/K220420
Methodology: https://510kreport.com/methodology