510(k) · Cleared

Cleared

Axyaflex Polyester Suture

K060165510(k) TraditionalCleared Sep 1, 2006221-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axya Medical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Sep 1, 2006 as substantially equivalent to K990088 (Aesculap, Inc., 1999) and 4 other predicates after a 221-day review. Its family tree reaches back 1 generation to 1990. 11 later devices descend from it.

Decided: Sep 1, 2006
Review: 221 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K902873 (1990). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK902873 Nonabsorbable Dacron Surgical Suture*United States Surgical, A Division of Tyco Healthc · 1990
This deviceK060165 Axyaflex Polyester SutureAxya Medical, Inc. · 2006
Descendant · cites it directly · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
Descendant · 2 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
Descendant · 2 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
Descendant · 3 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
Descendant · 3 generations on · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006high 2 (2018) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all

K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · cites it directly9descendants
K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 2 generations on4descendants
K173747RexleneSm Eng Co., Ltd. · 2018 · 2 generations on1descendant
K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 3 generations on1descendant
K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902873	Nonabsorbable Dacron Surgical Suture*	United States Surgical, A Division of Tyco Healthc	1990	—
0 (this device)	K060165	Axyaflex Polyester Suture	Axya Medical, Inc.	2006	—
+1	K080684	WG-Surgical Sutures with Needle	Foosin Medical Supplies, Inc.	2008	—
+2	K161633	Rexlon, Rexsil	Sm Eng Co., Ltd.	2017	—
+2	K173747	Rexlene	Sm Eng Co., Ltd.	2018	—
+3	K180701	SafePath Suturing System	Safepath Medical, Inc.	2018	—
+3	K222944	SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide…	Safepath Medical, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1999	1	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2015	1	0
2017	1	0
2018	2	0
2022	1	0
2023	2	0
2024	2	0

FIG. 1 — Lineage of K060165, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GAT device

#1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K990088	Synthofil Nonabsorbable Pet Surgical Suture Summary page 1 …21 CFR 878.5000 Predicate Devices Aesculap, Inc. Synthofil TM PET Sutures [510 (k) Number K990088] Genzyme Surgical Nextstitch T PET Sutures [510(k) Number K001440]…	Aesculap, Inc.	1999	—
*	K001440	Nextstitch Cardiovascular Valve Suture Summary page 1 …tures [510 (k) Number K990088] Genzyme Surgical Nextstitch T PET Sutures [510(k) Number K001440] United States Surgical Corp. Nonabsorbable Dacron® sutures [510(k)…	Genzyme Surgical Product (Genzyme Biosurgery)	2000	1
*	K902873	Nonabsorbable Dacron Surgical Suture* Summary page 1 …[510(k) Number K001440] United States Surgical Corp. Nonabsorbable Dacron® sutures [510(k) Number K902873] Sharpoint, Inc. Dacron® Sutures [510(k) Number K904263]…	United States Surgical, A Division of Tyco Healthc	1990	—
*	K904263	Dacron R Surgical Sutures Summary page 1 …e Dacron® sutures [510(k) Number K902873] Sharpoint, Inc. Dacron® Sutures [510(k) Number K904263] 19 Ethicon, Inc. Mers…	Sharppoint, Inc.	1990	—
*	K001434	'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture Summary page 2 …nt device Genzyme Surgical Products "Cottony" II Dacron Polyester Nonabsorbable Suture [501(k) Number K001434] Description AxyaFlexTM polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene tere…	Genzyme Surgical Product (Genzyme Biosurgery)	2000	1
*	—	Mersilene® Polyester Fiber Suture Named without a submission number			—

Also cleared against K990088: 2 other devices →

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080684	WG-Surgical Sutures with Needle	Foosin Medical Supplies, Inc.	2008	9
K063194	Tufflex Polyester Suture	Axya Medical, Inc.	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 5 ancestors have a recall of any class.
Of its descendants, K080684 (Foosin Medical Supplies, Inc., 2008) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K990088.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAT

1in 2011

2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAT

2,956in 2025

2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	40	1	15
2008	4	93	0	15
2009	9	57	0	55
2010	11	27	3	79
2011	1	—	1	97
2012	6	61	0	253
2013	4	123	0	210
2014	4	45	0	165
2015	7	125	0	626
2016	10	139	0	688
2017	6	57	0	1,104
2018	6	95	0	1,453
2019	4	79	0	1,251
2020	5	201	0	1,220
2021	4	92	0	1,643
2022	5	109	0	1,419
2023	8	220	0	2,038
2024	3	140	0	2,597
2025	5	30	0	2,956
2026	5	83	0	—

What is it indicated for?

AxyaFlexTM polyester suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060165: Axyaflex Polyester Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060165

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026