510(k) · Cleared

Cleared

Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM

K062747510(k) SpecialCleared Sep 29, 200615-day reviewClass II21 CFR 888.3030

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 Sep 29, 2006 as substantially equivalent to K031666 (Arthrex, Inc., 2003) after a 15-day review. Its family tree reaches back 5 generations to 1990. 143 later devices descend from it.

Decided: Sep 29, 2006
Review: 15 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K904436 (1990). 25 ancestors in all. 143 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
4 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
3 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
2 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
1 generation backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
This deviceK062747 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
Descendant · cites it directly · 38 of its ownK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2007high 16 (2023) · low 1 (2007)2026

Most influential descendants

Showing 5 of 143 · See all

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
K070780Conmed Linvatec XO ButtonConmed Linvatec · 2007 · cites it directly38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K904436	Quickanchor (TM)	Mitek Surgical Products, Inc.	1990	—
−4	K962397	Statak Soft Tissue Attachment Device	Zimmer, Inc.	1996	—
−3	K973015	Multitak SS Suture System	Bonutti Research	1997	—
−2	K990156	Multitak SS Buttons	Bonutti Research	1999	—
−1	K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	1
0 (this device)	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	—
+1	K070780	Conmed Linvatec XO Button	Conmed Linvatec	2007	—

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
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2012	2	0
2013	3	0
2014	7	0
2015	6	0
2016	6	0
2017	6	0
2018	2	0
2019	13	0
2020	11	0
2021	13	0
2022	11	0
2023	16	0
2024	16	0
2025	11	0
2026	14	0

FIG. 1 — Lineage of K062747, 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? (1)

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
*	K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS Summary page 1 …GAP. 21 GFG 878.5030 Suture, nonabsorbable, silk Predicate Device: Arthrex FiberWire® Button Repair Kit, K031666 Device Description and Intended Use: The Arthrex RetroButtonTM is a pre-threaded button construct. The Arthrex RetroButtonTM for…	Arthrex, Inc.	2003	1

Also cleared against K031666: 4 other devices →

What descends from it? (143)

See all 143

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

Number	Device	Applicant	Decided	Descendants
K100652	Acl Tightrope	Arthrex, Inc.	2010	65
K123341	Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…	Arthrex, Inc.	2012	52
K070780	Conmed Linvatec XO Button	Conmed Linvatec	2007	38
K170388	ANCHORMAN Tibial Ligament Fixation Device	Summit Medical, Ltd.	2017	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 16 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
4 of the 25 ancestors have a recall of any class.
Of its descendants, K100652 (Arthrex, Inc., 2010) has gone furthest, with 65 descendants of its own.
4 other devices also cite its predicate K031666.

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 RetroButtonTM for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062747 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062747

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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