510(k) · Decided

Decided

Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237, AR-7238, AR-7239

K032245510(k) TraditionalDecided Jan 14, 2004176-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 Jan 14, 2004 as substantially equivalent to K010673 (Arthrex, Inc., 2001) and 3 other predicates after a 176-day review. Its family tree reaches back 3 generations to 1999. 37 later devices descend from it.

Decided: Jan 14, 2004
Review: 176 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K990088 (1999). 10 ancestors in all. 37 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
2 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
1 generation backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
This deviceK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
Descendant · cites it directly · 31 of its ownK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
Descendant · 2 generations on · 13 of its ownK122374 Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012
Descendant · cites it directly · 4 of its ownK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
Descendant · 2 generations on · 3 of its ownK170957 ReConnex Pre-Sutured TendonAllosource · 2018
Descendant · 3 generations on · 3 of its ownK171296 SutureTapeArthrex, Inc. · 2017

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2004high 5 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 37 · See all

K041553Arthrex Suture Grafting KitArthrex, Inc. · 2004 · cites it directly31descendants
K122374Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012 · 2 generations on13descendants
K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015 · cites it directly4descendants
K170957ReConnex Pre-Sutured TendonAllosource · 2018 · 2 generations on3descendants
K171296SutureTapeArthrex, Inc. · 2017 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap, Inc.	1999	—
−2	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
−1	K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	—
0 (this device)	K032245	Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape…	Arthrex, Inc.	2004	—
+1	K041553	Arthrex Suture Grafting Kit	Arthrex, Inc.	2004	—
+2	K122374	Arthrex Suture (Uhmwpe)	Arthrex, Inc.	2012	—
+1	K143702	Arthrex Blunt Tip Screws with Fiber Tape	Arthrex, Inc.	2015	—
+2	K170957	ReConnex Pre-Sutured Tendon	Allosource	2018	—
+3	K171296	SutureTape	Arthrex, Inc.	2017	—

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
2004	1	0
2007	1	0
2008	1	0
2012	2	0
2013	2	0
2014	1	0
2015	1	0
2016	2	0
2017	2	0
2018	2	0
2019	2	0
2020	2	0
2021	3	0
2022	2	0
2023	3	0
2024	1	0
2025	5	0
2026	4	0

FIG. 1 — Lineage of K032245, 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K010673	Arthrex Fiberwire, Model Spu-02NB-3800 Summary page 1 …TM Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K010673, Arthrex K012923, Arthrex K021434, Johnson & Johnson K012124, and Ethicon Endo- S…	Arthrex, Inc.	2001	—
*	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201 Summary page 1 …TM Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K010673, Arthrex K012923, Arthrex K021434, Johnson & Johnson K012124, and Ethicon Endo- Surgery Mersilene…	Arthrex, Inc.	2001	—
*	K021434	Arthrex Fiberwire in Usp Sizes Summary page 1 …TM Product Code: GAT Classification Name: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K010673, Arthrex K012923, Arthrex K021434, Johnson & Johnson K012124, and Ethicon Endo- Surgery Mersilene Tape. This summa…	Arthrex, Inc.	2002	—
*	K012124	Mersilk Black Silk Braided Non-Absorbable Suture, Usp Summary page 1 …ame: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices: Arthrex K010673, Arthrex K012923, Arthrex K021434, Johnson & Johnson K012124, and Ethicon Endo- Surgery Mersilene Tape. This summary of 510(k) safety and effectiveness information i…	Johnson & Johnson Medical (China), Ltd.	2001	—
*	—	Ethicon Endo-Surgery Mersilene Tape Named without a submission number			—

Also cleared against K010673: 7 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K041553	Arthrex Suture Grafting Kit	Arthrex, Inc.	2004	31
K143702	Arthrex Blunt Tip Screws with Fiber Tape	Arthrex, Inc.	2015	4

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 10 ancestors have a recall of any class.
Of its descendants, K041553 (Arthrex, Inc., 2004) has gone furthest, with 31 descendants of its own.
7 other devices also cite its predicate K010673.

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 FiberTape TM Family suture products, like it's predecessor the FiberWire TM

Family, are intended for use in approximation and/or ligation of soft tissue, including

use of allograft tissue for orthopedic surgeries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032245: Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237, AR-7238, AR-7239.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032245

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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