510(k) · Cleared

Cleared

Arthrex Fiberwire, Usp Size 5, Model AR-7201

K012923510(k) TraditionalCleared Oct 4, 200134-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 Oct 4, 2001 as substantially equivalent to K010673 (Arthrex, Inc., 2001) and 5 other predicates after a 34-day review. Its family tree reaches back 1 generation to 1999. 260 later devices descend from it.

Decided: Oct 4, 2001
Review: 34 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K990088 (1999). 6 ancestors in all. 260 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
This deviceK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
Descendant · cites it directly · 259 of its ownK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
Descendant · cites it directly · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
Descendant · 2 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
Descendant · 2 generations on · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
Descendant · 2 generations on · 65 of its ownK100652 Acl TightropeArthrex, Inc. · 2010

Showing 5 of 260 descendants. See all descendants

Descendants cleared per year

2002high 24 (2023) · low 1 (2002)2026

Most influential descendants

Showing 5 of 260 · See all

K021434Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002 · cites it directly259descendants
K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · cites it directly161descendants
K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · 2 generations on143descendants
K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · 2 generations on69descendants
K100652Acl TightropeArthrex, Inc. · 2010 · 2 generations on65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap, Inc.	1999	—
0 (this device)	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
+1	K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	—
+1	K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	1
+2	K062747	Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM	Arthrex, Inc.	2006	—
+2	K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	1
+2	K100652	Acl Tightrope	Arthrex, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	3	0
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	4	0
2005	2	0
2006	1	0
2007	5	0
2008	2	0
2009	8	0
2010	4	0
2011	3	0
2012	6	0
2013	9	0
2014	15	0
2015	17	0
2016	9	0
2017	10	0
2018	10	0
2019	19	0
2020	16	0
2021	18	0
2022	12	0
2023	24	0
2024	24	0
2025	20	0
2026	20	0

FIG. 1 — Lineage of K012923, 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? (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
*	K010673	Arthrex Fiberwire, Model Spu-02NB-3800 Summary page 1 …/Proprietary Name: Arthrex Fiberwire™ USP size 5 suture Product Code: GAT Classification Name: Suturem Nonabsorbable, Synthetic, Polyester Predicate Devices: Arthrex, K010673, Grams American Suture, K003590, Aesculap, Inc., K990088, ARC Medical Supplies, K000540, Genzyme Surgical Product, K001434, and…	Arthrex, Inc.	2001	—
*	K003590	Grams Polyester Nonabsorbable Suture Summary page 1 …wire™ USP size 5 suture Product Code: GAT Classification Name: Suturem Nonabsorbable, Synthetic, Polyester Predicate Devices: Arthrex, K010673, Grams American Suture, K003590, Aesculap, Inc., K990088, ARC Medical Supplies, K000540, Genzyme Surgical Product, K001434, and C.P. Medical, K0O01172 This sum…	Gramsmed, LLC	2001	—
*	K990088	Synthofil Nonabsorbable Pet Surgical Suture Summary page 1 …Product Code: GAT Classification Name: Suturem Nonabsorbable, Synthetic, Polyester Predicate Devices: Arthrex, K010673, Grams American Suture, K003590, Aesculap, Inc., K990088, ARC Medical Supplies, K000540, Genzyme Surgical Product, K001434, and C.P. Medical, K0O01172 This summary of 510(k) safety and…	Aesculap, Inc.	1999	—
*	K000540	Polyester Nonabsorbable Surgical Sutures, Usp Summary page 1 …on Name: Suturem Nonabsorbable, Synthetic, Polyester Predicate Devices: Arthrex, K010673, Grams American Suture, K003590, Aesculap, Inc., K990088, ARC Medical Supplies, K000540, Genzyme Surgical Product, K001434, and C.P. Medical, K0O01172 This summary of 510(k) safety and effectiveness information is b…	Arc Medical Supplies (Beijing) Co, Ltd.	2000	—
*	K001434	'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture Summary page 1 …thetic, Polyester Predicate Devices: Arthrex, K010673, Grams American Suture, K003590, Aesculap, Inc., K990088, ARC Medical Supplies, K000540, Genzyme Surgical Product, K001434, and C.P. Medical, K0O01172 This summary of 510(k) safety and effectiveness information is being submitted in accordance with t…	Genzyme Surgical Product (Genzyme Biosurgery)	2000	1
*	K001172	Polyester Nonabsorbable Surgical Sutures Urp	Cp Medical	2000	1

Also cleared against K010673: 7 other devices →

What descends from it? (260)

See all 260

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

Number	Device	Applicant	Decided	Descendants
K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	259
K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	161
K032245	Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…	Arthrex, Inc.	2004	37
K041553	Arthrex Suture Grafting Kit	Arthrex, Inc.	2004	31

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 6 ancestors have a recall of any class.
Of its descendants, K021434 (Arthrex, Inc., 2002) has gone furthest, with 259 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 Fiberwire™ USP size 5 suture is intended for use in soft tissue approximation and or ligation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012923 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012923

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026