510(k) · Cleared

Recalled · Class II · 2016

Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS

K031666510(k) TraditionalCleared Nov 18, 2003173-day reviewClass II21 CFR 888.3030Recalls 1

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

Arthrex, Inc. · HRS Plate, Fixation, Bone

Cleared on Nov 18, 2003 as substantially equivalent to K010673 (Arthrex, Inc., 2001) and 7 other predicates after a 173-day review. Its family tree reaches back 4 generations to 1990. 161 later devices descend from it. It has been recalled once.

Decided: Nov 18, 2003
Review: 173 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 8

Its longest line of descent runs back 4 generations to K904436 (1990). 24 ancestors in all. 161 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
2 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
1 generation backK990156 Multitak SS ButtonsBonutti Research · 1999
This deviceK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003
Descendant · cites it directly · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
Descendant · cites it directly · 65 of its ownK100652 Acl TightropeArthrex, Inc. · 2010
Descendant · cites it directly · 52 of its ownK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
Descendant · 2 generations on · 49 of its ownK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
Descendant · 2 generations on · 40 of its ownK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015

Showing 5 of 161 descendants. See all descendants

Descendants cleared per year

2005high 17 (2023) · low 1 (2005)2026

Most influential descendants

Showing 5 of 161 · See all

K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · cites it directly143descendants
K100652Acl TightropeArthrex, Inc. · 2010 · cites it directly65descendants
K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · cites it directly52descendants
K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011 · 2 generations on49descendants
K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015 · 2 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K904436	Quickanchor (TM)	Mitek Surgical Products, Inc.	1990	—
−3	K962397	Statak Soft Tissue Attachment Device	Zimmer, Inc.	1996	—
−2	K973015	Multitak SS Suture System	Bonutti Research	1997	—
−1	K990156	Multitak SS Buttons	Bonutti Research	1999	—
0 (this device)	K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	—
+1	K062747	Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM	Arthrex, Inc.	2006	—
+1	K100652	Acl Tightrope	Arthrex, Inc.	2010	—
+1	K123341	Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button…	Arthrex, Inc.	2012	—
+2	K112990	Acl Tightrope,Acl Tightrope Duuble Bundle	Arthrex, Inc.	2011	—
+2	K150768	JuggerKnot Soft Anchors	Biomet Manufacturing Corp	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	1	0
1994	1	0
1995	1	0
1996	3	0
1997	1	0
1998	2	0
1999	2	0
2000	3	0
2001	3	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2011	3	0
2012	2	0
2013	3	0
2014	10	0
2015	8	0
2016	6	0
2017	6	0
2018	3	0
2019	15	0
2020	12	0
2021	14	0
2022	11	0
2023	17	0
2024	17	0
2025	13	0
2026	14	0

FIG. 1 — Lineage of K031666, 1990–2026Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (8)

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 …ade/Proprietary Name: Arthrex ACL RetroConstructionTMButton Kit Product Code: HRS Classification Name: Plate, Fixation, Bone Predicate Devices: Arthrex K010673, Arthrex KO12923, Arthrex K021434, Smith & Nephew K980155, Karl Storz Endoscopy-…	Arthrex, Inc.	2001	—
*	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
*	K021434	Arthrex Fiberwire in Usp Sizes Summary page 1 …RetroConstructionTMButton Kit Product Code: HRS Classification Name: Plate, Fixation, Bone Predicate Devices: Arthrex K010673, Arthrex KO12923, Arthrex K021434, Smith & Nephew K980155, Karl Storz Endoscopy- America, Inc. K022853, DePuy ACE K…	Arthrex, Inc.	2002	—
*	K980155	Endobutton Continuous Loop Summary page 1 …HRS Classification Name: Plate, Fixation, Bone Predicate Devices: Arthrex K010673, Arthrex KO12923, Arthrex K021434, Smith & Nephew K980155, Karl Storz Endoscopy- America, Inc. K022853, DePuy ACE K990120, DePuy ACE K98234…	Smith & Nephew, Inc.	1998	—
*	K022853	Endotack Summary page 1 …ices: Arthrex K010673, Arthrex KO12923, Arthrex K021434, Smith & Nephew K980155, Karl Storz Endoscopy- America, Inc. K022853, DePuy ACE K990120, DePuy ACE K982347, and Bonutti Research K990156. This summary of 510(k) safety and…	KARL STORZ Endoscopy-America, Inc.	2002	—
*	K990120	Modification of Depuy Ace Timax Medial Pilon Plate Summary page 1 …K010673, Arthrex KO12923, Arthrex K021434, Smith & Nephew K980155, Karl Storz Endoscopy- America, Inc. K022853, DePuy ACE K990120, DePuy ACE K982347, and Bonutti Research K990156. This summary of 510(k) safety and effectiveness infor…	Depuy Ace Medical Co.	1999	—
*	K982347	Depuy Ace Timax Pilon Plate Summary page 1 …Smith & Nephew K980155, Karl Storz Endoscopy- America, Inc. K022853, DePuy ACE K990120, DePuy ACE K982347, and Bonutti Research K990156. This summary of 510(k) safety and effectiveness information is being submitted in accordance wit…	Depuy Ace Medical Co.	1998	—
*	K990156	Multitak SS Buttons Summary page 1 …& Nephew K980155, Karl Storz Endoscopy- America, Inc. K022853, DePuy ACE K990120, DePuy ACE K982347, and Bonutti Research K990156. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 8…	Bonutti Research	1999	—

Also cleared against K010673: 7 other devices →

What descends from it? (161)

See all 161

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

Number	Device	Applicant	Decided	Descendants
K062747	Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM	Arthrex, Inc.	2006	143
K100652	Acl Tightrope	Arthrex, Inc.	2010	65
K123341	Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…	Arthrex, Inc.	2012	52
K090107	Mini Tightrope	Arthrex, Inc.	2009	21
K052901	Arthrex Tensionlok	Arthrex, Inc.	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 11, 2016	Class II	Z-1360-2016	Other	Potential for a component contained in the Implant System to be non-sterile.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
3 of the 24 ancestors have a recall of any class.
Of its descendants, K062747 (Arthrex, Inc., 2006) has gone furthest, with 143 descendants of its own.
7 other devices also cite its predicate K010673.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The Arthrex ACL RetroConstructionTMButton Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWireTMor equivalent. Specifically, Arthrex will be offering this for ACL repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031666 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031666

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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