510(k) · Cleared

Cleared

Arthrex AlloSync PushLock Suture Anchor

K233971510(k) TraditionalCleared Jun 4, 2024172-day reviewClass II21 CFR 888.3030

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

Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jun 4, 2024 as substantially equivalent to K063479 (Arthrex, Inc., 2006) after a 172-day review. Its family tree reaches back 2 generations to 2005.

Decided: Jun 4, 2024
Review: 172 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K050749 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK050749 Arthrex Tak FamilyArthrex, Inc. · 2005
1 generation backK063479 Arthrex PushlockArthrex, Inc. · 2006
This deviceK233971 Arthrex AlloSync PushLock Suture AnchorArthrex, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K050749	Arthrex Tak Family	Arthrex, Inc.	2005	—
−1	K063479	Arthrex Pushlock	Arthrex, Inc.	2006	—
0 (this device)	K233971	Arthrex AlloSync PushLock Suture Anchor	Arthrex, Inc.	2024	—

FIG. 1 — Lineage of K233971, 2005–2024Source: 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 MAI? 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 MAI device

#1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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
*	K063479	Arthrex Pushlock Summary page 5 …ue 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K063479: Arthrex 2.5mm PushLock Reference Device K070347: Allofix Push-In Anchor Purpose of Submission This Traditional 510(k) p…	Arthrex, Inc.	2006	—
†	K070347	Allofix Push-in Anchor	Musculoskeletal Transplant Foundation	2007	—

Also cleared against K063479: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 17.5 years on median.
None of the 2 ancestors has a recall.
16 other devices also cite its predicate K063479.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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	4	100	0	272
2008	3	83	0	172
2009	9	74	0	88
2010	4	122	0	89
2011	9	90	5	129
2012	6	56	10	171
2013	6	135	0	166
2014	4	86	0	149
2015	5	95	0	182
2016	3	191	0	301
2017	9	113	0	478
2018	13	108	0	1,590
2019	9	41	2	1,248
2020	9	78	40	957
2021	8	115	0	1,267
2022	6	136	0	1,425
2023	8	34	0	1,718
2024	7	53	0	2,300
2025	8	54	0	2,148
2026	5	69	1	—

What is it indicated for?

The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior to Posterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K233971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K233971: Arthrex AlloSync PushLock Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233971

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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