510(k) · Cleared

Cleared

Endobutton Continuous Loop

K980155510(k) TraditionalCleared Apr 1, 199875-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

Smith & Nephew, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Apr 1, 1998 as substantially equivalent to K922559 (Acufex Microsurgical, Inc., 1992) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1992. 347 later devices descend from it.

Decided: Apr 1, 1998
Review: 75 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K922559 (1992). 2 ancestors in all. 347 later devices descend from it, 14 citing it directly.

By dateBy generation

Root · 1 generation backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
This deviceK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
Descendant · cites it directly · 310 of its ownK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
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

Showing 5 of 347 descendants. See all descendants

Descendants cleared per year

1999high 37 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 347 · See all

K984550Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999 · cites it directly310descendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922559	Acufex Endofix Button	Acufex Microsurgical, Inc.	1992	—
0 (this device)	K980155	Endobutton Continuous Loop	Smith & Nephew, Inc.	1998	—
+1	K984550	Pre-Threaded Endobutton	Smith & Nephew, Inc.	1999	—
+2	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+3	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—
+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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0
2004	2	0
2005	4	0
2006	3	0
2007	2	0
2008	5	0
2009	3	0
2010	1	0
2011	8	0
2012	4	0
2013	10	0
2014	18	0
2015	11	0
2016	8	0
2017	18	0
2018	15	0
2019	28	0
2020	24	0
2021	24	0
2022	26	0
2023	27	0
2024	35	0
2025	32	0
2026	37	0

FIG. 1 — Lineage of K980155, 1992–2026Source: 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? (2)

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
*	K922559	Acufex Endofix Button Summary page 3 …and the substantially equivalent devices is presented in the table below. EndoButton Continuous Loop 510K bute EndoButton Continuous EndoButton EndoButton Tape y Loop K922559 K952535 Indication Fixation of tendons and Soft Tissue Fixation Soft tissue approximation ligaments during and Repair specificall…	Acufex Microsurgical, Inc.	1992	—
*	K952535	Acufex Endobutton Tape Summary page 3 …substantially equivalent devices is presented in the table below. EndoButton Continuous Loop 510K bute EndoButton Continuous EndoButton EndoButton Tape y Loop K922559 K952535 Indication Fixation of tendons and Soft Tissue Fixation Soft tissue approximation ligaments during and Repair specifically for us…	Acufex Microsurgical, Inc.	1996	2

Also cleared against K922559: 1 other device →

What descends from it? (347)

See all 347

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

Number	Device	Applicant	Decided	Descendants
K984550	Pre-Threaded Endobutton	Smith & Nephew, Inc.	1999	310
K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	161
K033838	Titanium Toggle Button (S)	Biomet Manufacturing, Inc.	2004	97
K070780	Conmed Linvatec XO Button	Conmed Linvatec	2007	38
K102982	Endobutton Direct	Smith & Nephew Inc., Endoscopy Division	2011	36
K090923	Parcus Graft Fixation System	Parcus Medical, LLC	2009	21
K130217	Orthopediatrics Acl Reconstructive System	OrthoPediatrics Corp.	2013	4
K130814	Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM	Depuy Mitek, A Johnson & Johnson Company	2013	3
K080974	TLS Fixation System	Fournitures Hospitalieres Industrie	2008	2
K151601	Secure-Loop	Xiros, Ltd.	2015	1

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K984550 (Smith & Nephew, Inc., 1999) has gone furthest, with 310 descendants of its own.
1 other device also cites its predicate K922559.

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 EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

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/K980155 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980155: Endobutton Continuous Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980155

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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