# K063194: Tufflex Polyester Suture

- Pathway: 510(k) (Special)
- Applicant: Axya Medical, Inc.
- Decided: Dec 4, 2006 after 45 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K902873 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060165: Axyaflex Polyester Suture, Axya Medical, Inc. (2006) Summary page 1.
- K040789: Durabraid Suture, Smith & Nephew, Inc. (2004) Summary page 1.

## Indications for use
TufflexTM Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K063194
Methodology: https://510kreport.com/methodology