510(k) · Cleared

Recalled · Class II · 2018

Arthrex NanoSuture Anchor

K180118510(k) SpecialCleared Feb 12, 201827-day reviewClass II21 CFR 888.3040Recalls 1

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

Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Feb 12, 2018 as substantially equivalent to K112237 (Arthrex, Inc., 2011) after a 27-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it. It has been recalled once.

Decided: Feb 12, 2018
Review: 27 days
Class: Class II
Product code: MBI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 7 generations to K961555 (1996). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
2 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
1 generation backK112237 Microsuture AnchorsArthrex, Inc. · 2011
This deviceK180118 Arthrex NanoSuture AnchorArthrex, Inc. · 2018
Descendant · cites it directly · 1 of its ownK223114 Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda. · 2023
Descendant · 2 generations on · 0 of its ownK253027 Anchor with Fiber Wire and Disposable InserterOrtobio S.A. · 2026

Most influential descendants

Showing 2 of 2 · See all

K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda. · 2023 · cites it directly1descendant
K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−6	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−5	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−4	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex, Inc.	2006	—
−3	K071177	Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…	Arthrex, Inc.	2007	—
−2	K091844	Arthrex Bio-Composite Suturetak Anchors	Arthrex, Inc.	2009	—
−1	K112237	Microsuture Anchors	Arthrex, Inc.	2011	—
0 (this device)	K180118	Arthrex NanoSuture Anchor	Arthrex, Inc.	2018	—
+1	K223114	Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors	Gm Dos Reis Industria E Comerico Ltda.	2023	—
+2	K253027	Anchor with Fiber Wire and Disposable Inserter	Ortobio S.A.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2005	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0
2026	1	0

FIG. 1 — Lineage of K180118, 1996–2026Source: 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? (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
*	K112237	Microsuture Anchors Summary page 4 …tion, bone Product Code MBI Classification Name 21 CFR 888.3040: Fastener, Fixation, Nondegradable, Soft Tissue Regulatory Class II Predicate Device K112237: Arthrex MicroSuture Anchors Purpose of This Special 510(k) premarket notification is submitted to obtain clearance fo…	Arthrex, Inc.	2011	—

Also cleared against K112237: 6 other devices →

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
K223114	Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors	Gm Dos Reis Industria E Comerico Ltda.	2023	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 19, 2018	Class II	Z-0724-2019	Process control	Potentially lead to anchor breakage during insertion,

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
2 of the 10 ancestors have a recall of any class.
Of its descendants, K223114 (Gm Dos Reis Industria E Comerico Ltda., 2023) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K112237.

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. 2018, 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 Arthrex NanoSuture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction…

Read the full statement (134 words)

The Arthrex NanoSuture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180118 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180118: Arthrex NanoSuture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180118

Report an extraction error

Are you the manufacturer?

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