510(k) · Cleared

Cleared

Acufex Endofix Button

K922559510(k) TraditionalCleared Dec 24, 1992209-day reviewClass II21 CFR 872.3770

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

Acufex Microsurgical, Inc. · EBG Crown And Bridge, Temporary, Resin

Cleared on Dec 24, 1992 after a 209-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 349 later devices descend from it.

Decided: Dec 24, 1992
Review: 209 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 0

349 later devices descend from it, 2 citing it directly.

This deviceK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
Descendant · cites it directly · 347 of its ownK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
Descendant · 2 generations on · 310 of its ownK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
Descendant · 2 generations on · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled

Showing 5 of 349 descendants. See all descendants

Descendants cleared per year

1998high 37 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 349 · See all

K980155Endobutton Continuous LoopSmith & Nephew, Inc. · 1998 · cites it directly347descendants
K984550Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999 · 2 generations on310descendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · 2 generations on161descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922559	Acufex Endofix Button	Acufex Microsurgical, Inc.	1992	—
+1	K980155	Endobutton Continuous Loop	Smith & Nephew, Inc.	1998	—
+2	K984550	Pre-Threaded Endobutton	Smith & Nephew, Inc.	1999	—
+3	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+4	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—
+2	K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2003	1	0
2004	2	0
2005	4	0
2006	3	0
2007	3	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 K922559, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EBG? 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 EBG device

#1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (349)

See all 349

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

Number	Device	Applicant	Decided	Descendants
K980155	Endobutton Continuous Loop	Smith & Nephew, Inc.	1998	347
K070167	Endobutton Direct	Smith & Nephew Inc., Endoscopy Division	2007	2

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?

Of its descendants, K980155 (Smith & Nephew, Inc., 1998) has gone furthest, with 347 descendants of its own.

How does its category compare?

All EBG devices

EBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBG

4in 2025

2007high 14 (2020) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBG

106in 2025

2007high 265 (2021) · low 64 (2007)2026

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

Recalls per year · EBG

1in 2020

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EBG

1in 2025

2007high 26 (2015) · low 0 (2018)2025

MAUDE reports naming product code EBG, 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	3	64	0	4
2008	9	83	0	4
2009	2	—	1	1
2010	5	103	0	1
2011	10	96	0	1
2012	5	90	0	5
2013	2	—	0	11
2014	3	114	0	23
2015	6	209	0	26
2016	4	163	0	8
2017	2	—	0	4
2018	4	202	0	0
2019	6	98	0	6
2020	14	194	1	2
2021	3	265	0	4
2022	3	73	0	2
2023	2	—	0	0
2024	5	144	0	0
2025	4	106	0	1
2026	2	—	0	—

https://510kreport.com/device/K922559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922559: Acufex Endofix Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922559

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026