# K060165: Axyaflex Polyester Suture

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Sep 1, 2006 after 221 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: 1 generation back to K902873 (1990). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990088: Synthofil Nonabsorbable Pet Surgical Suture, Aesculap, Inc. (1999) Summary page 1.
- K001440: Nextstitch Cardiovascular Valve Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000) Summary page 1.
- K902873: Nonabsorbable Dacron Surgical Suture*, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K904263: Dacron R Surgical Sutures, Sharppoint, Inc. (1990) Summary page 1.
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000) Summary page 2.
- (no number) Mersilene® Polyester Fiber Suture: named in the summary without a submission number

## Most influential descendants
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K173747: Rexlene (2018), 1 descendant of its own
- K180701: SafePath Suturing System (2018), 1 descendant of its own
- K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (2024), 0 descendants of its own

## Indications for use
AxyaFlexTM 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/K060165
Methodology: https://510kreport.com/methodology