510(k) · Cleared

Cleared

Endotack

K022853510(k) TraditionalCleared Nov 25, 200290-day reviewClass II21 CFR 888.3040

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

KARL STORZ Endoscopy-America, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Nov 25, 2002 after a 90-day review. The FDA summary names no predicate by number. 165 later devices descend from it.

Decided: Nov 25, 2002
Review: 90 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

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

This deviceK022853 EndotackKARL STORZ Endoscopy-America, 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 · 65 of its ownK100652 Acl TightropeArthrex, Inc. · 2010
Descendant · 2 generations on · 52 of its ownK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
Descendant · 3 generations on · 49 of its ownK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011

Showing 5 of 165 descendants. See all descendants

Descendants cleared per year

2003high 18 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 165 · See all

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
K100652Acl TightropeArthrex, Inc. · 2010 · 2 generations on65descendants
K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · 2 generations on52descendants
K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011 · 3 generations on49descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022853	Endotack	KARL STORZ Endoscopy-America, 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	K100652	Acl Tightrope	Arthrex, Inc.	2010	—
+2	K123341	Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button…	Arthrex, Inc.	2012	—
+3	K112990	Acl Tightrope,Acl Tightrope Duuble Bundle	Arthrex, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
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	7	0
2018	3	0
2019	16	0
2020	12	0
2021	14	0
2022	11	0
2023	18	0
2024	17	0
2025	13	0
2026	14	0

FIG. 1 — Lineage of K022853, 2002–2026Source: 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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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?

The FDA summary names no predicate by number.

What descends from it? (165)

See all 165

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

Number	Device	Applicant	Decided	Descendants
K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	161
K171640	M-ARS ACL: Anatomic Ribbon Surgery System	Medacta International S.A.	2017	5

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, K031666 (Arthrex, Inc., 2003) has gone furthest, with 161 descendants of its own.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022853 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022853: Endotack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022853

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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