510(k) · Cleared

Cleared

Arthrex Suture Grafting Kit

K041553510(k) TraditionalCleared Dec 10, 2004184-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

Arthrex, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Dec 10, 2004 as substantially equivalent to K032245 (Arthrex, Inc., 2004) and 6 other predicates after a 184-day review. Its family tree reaches back 4 generations to 1999. 31 later devices descend from it.

Decided: Dec 10, 2004
Review: 184 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K990088 (1999). 11 ancestors in all. 31 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
1 generation backK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
This deviceK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
Descendant · cites it directly · 13 of its ownK122374 Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012
Descendant · cites it directly · 3 of its ownK170957 ReConnex Pre-Sutured TendonAllosource · 2018
Descendant · 2 generations on · 3 of its ownK171296 SutureTapeArthrex, Inc. · 2017
Descendant · cites it directly · 3 of its ownK112899 Arthrex Bio-SutureArthrex, Inc. · 2012
Descendant · cites it directly · 3 of its ownK071622 Arthrex FiberwireArthrex, Inc. · 2007

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2007high 4 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all

K122374Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012 · cites it directly13descendants
K170957ReConnex Pre-Sutured TendonAllosource · 2018 · cites it directly3descendants
K171296SutureTapeArthrex, Inc. · 2017 · 2 generations on3descendants
K112899Arthrex Bio-SutureArthrex, Inc. · 2012 · cites it directly3descendants
K071622Arthrex FiberwireArthrex, Inc. · 2007 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap, Inc.	1999	—
−3	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
−2	K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	—
−1	K032245	Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape…	Arthrex, Inc.	2004	—
0 (this device)	K041553	Arthrex Suture Grafting Kit	Arthrex, Inc.	2004	—
+1	K122374	Arthrex Suture (Uhmwpe)	Arthrex, Inc.	2012	—
+1	K170957	ReConnex Pre-Sutured Tendon	Allosource	2018	—
+2	K171296	SutureTape	Arthrex, Inc.	2017	—
+1	K112899	Arthrex Bio-Suture	Arthrex, Inc.	2012	—
+1	K071622	Arthrex Fiberwire	Arthrex, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	4	0
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2012	2	0
2013	2	0
2014	1	0
2016	2	0
2017	2	0
2018	2	0
2019	2	0
2020	1	0
2021	2	0
2022	2	0
2023	3	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K041553, 1999–2026Source: 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

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What was it cleared against? (7)

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
*	K032245	Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM… Summary page 1 …ietary Name: Arthrex Suture Grafting Kit Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K032245, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590…	Arthrex, Inc.	2004	—
*	K021434	Arthrex Fiberwire in Usp Sizes Summary page 1 …rex Suture Grafting Kit Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K032245, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590 Arthrex K012923,…	Arthrex, Inc.	2002	—
*	K010673	Arthrex Fiberwire, Model Spu-02NB-3800 Summary page 1 …ng Kit Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K032245, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590 Arthrex K012923, ARC Medical Supp…	Arthrex, Inc.	2001	—
*	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201 Summary page 1 …fication Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K032245, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590 Arthrex K012923, ARC Medical Supplies K000540, Gen…	Arthrex, Inc.	2001	—
*	K003590	Grams Polyester Nonabsorbable Suture Summary page 1 …bsorbable, Synthetic, Polyester Predicate Devices: Arthrex K032245, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product K001434.…	Gramsmed, LLC	2001	—
*	K000540	Polyester Nonabsorbable Surgical Sutures, Usp Summary page 1 …5, Arthrex K021434, Arthrex K010673, Arthrex K012923, Grams American Suture K003590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product K001434. This summary of 510(k) safety and effectiveness information is being…	Arc Medical Supplies (Beijing) Co, Ltd.	2000	—
*	K001434	'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture Summary page 1 …Arthrex K012923, Grams American Suture K003590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product K001434. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 80…	Genzyme Surgical Product (Genzyme Biosurgery)	2000	1

Also cleared against K032245: 1 other device →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K122374	Arthrex Suture (Uhmwpe)	Arthrex, Inc.	2012	13
K170957	ReConnex Pre-Sutured Tendon	Allosource	2018	3
K112899	Arthrex Bio-Suture	Arthrex, Inc.	2012	3
K071622	Arthrex Fiberwire	Arthrex, Inc.	2007	3
K181633	MTF Pre-Sutured Tendon	Musculoskeletal Transplant Foundation	2019	2
K130458	Knotless Fibertak Suture Anchor	Arthrex, Inc.	2013	2
K181182	DYNACORD Suture	Medos International SARL	2018	1
K213046	AceConnex Pre-Sutured Fascia	Allosource	2023	0
K212146	Arthrex LoopLoc Knotless Suture	Arthrex, Inc.	2021	0
K123668	Orthocord	Depuy Mitek, Inc., A Johnson and Johnson Company	2013	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?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
2 of the 11 ancestors have a recall of any class.
Of its descendants, K122374 (Arthrex, Inc., 2012) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K032245.

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?

The Arthrex Fiberwire TM and FiberTape TM Families are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041553: Arthrex Suture Grafting Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041553

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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