510(k) · Cleared

Cleared

Arthrex PushLock Tenodesis Anchor

K181513510(k) SpecialCleared Aug 30, 201883-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

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

Cleared on Aug 30, 2018 as substantially equivalent to K051726 (Arthrex, Inc., 2005) after an 83-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Aug 30, 2018
Review: 83 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051726 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK051726 Arthrex Tenodesis FamilyArthrex, Inc. · 2005
This deviceK181513 Arthrex PushLock Tenodesis AnchorArthrex, Inc. · 2018
Descendant · cites it directly · 0 of its ownK254229 Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all

K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051726	Arthrex Tenodesis Family	Arthrex, Inc.	2005	—
0 (this device)	K181513	Arthrex PushLock Tenodesis Anchor	Arthrex, Inc.	2018	—
+1	K254229	Arthrex Nano FiberTak Suture Anchor	Arthrex, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K181513, 2005–2026Source: 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

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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
*	K051726	Arthrex Tenodesis Family Summary page 4 …Code MBI Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K051726: Arthrex Tenodesis Family Reference Predicate K101679: Arthrex PushLock K101823: SwiveLock Sutu…	Arthrex, Inc.	2005	—
†	K101679	Arthrex Pushlock Anchors	Arthrex, Inc.	2010	—
†	K101823	Arthrex Swivelock Anchors	Arthrex, Inc.	2011	6

Also cleared against K051726: 12 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K254229	Arthrex Nano FiberTak Suture Anchor	Arthrex, Inc.	2026	0

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, K254229 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.
12 other devices also cite its predicate K051726.

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 Tenodesis PushLock Anchor is intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically; Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial…

Read the full statement (144 words)

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181513 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181513: Arthrex PushLock Tenodesis Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181513

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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