510(k) · Cleared

Cleared

Endobutton Direct

K070167510(k) TraditionalCleared Apr 12, 200784-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

Smith & Nephew Inc., Endoscopy Division · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Apr 12, 2007 as substantially equivalent to K922559 (Acufex Microsurgical, Inc., 1992) after an 84-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.

Decided: Apr 12, 2007
Review: 84 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

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

By dateBy generation

Root · 1 generation backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
This deviceK070167 Endobutton DirectSmith & Nephew Inc., Endoscopy Division · 2007
Descendant · cites it directly · 1 of its ownK101616 The Grapplr and Grapplr ExtenderTag Medical Corp. · 2011
Descendant · 2 generations on · 0 of its ownK142653 G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd. · 2014

Most influential descendants

Showing 2 of 2 · See all

K101616The Grapplr and Grapplr ExtenderTag Medical Corp. · 2011 · cites it directly1descendant
K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd. · 2014 · 2 generations on0descendants

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)	K070167	Endobutton Direct	Smith & Nephew Inc., Endoscopy Division	2007	—
+1	K101616	The Grapplr and Grapplr Extender	Tag Medical Corp.	2011	—
+2	K142653	G-Lok and G-Lok XL Extender	T.A.G. Medical Products Corporation, Ltd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	1	0

FIG. 1 — Lineage of K070167, 1992–2014Source: 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
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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
*	K922559	Acufex Endofix Button Summary page 1 …t in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew EndoButton (K922559). E. Description of Device The EndoButton Direct is a machined titanium implant designed to provide cortical fixat…	Acufex Microsurgical, Inc.	1992	—
†	K980155	Endobutton Continuous Loop	Smith & Nephew, Inc.	1998	—

Also cleared against K922559: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101616	The Grapplr and Grapplr Extender	Tag Medical Corp.	2011	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?

Its one ancestor has no recall.
Of its descendants, K101616 (Tag Medical Corp., 2011) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K922559.

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. 2007, this device’s year, is highlighted.

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 Smith & Nephew EndoButton Direct Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070167: Endobutton Direct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070167

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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