510(k) · Cleared

Cleared

Arthrex Wrist Bio-Anchor, Model AR-1322B

K022234510(k) TraditionalCleared Oct 3, 200284-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. · HWC Screw, Fixation, Bone

Cleared on Oct 3, 2002 after an 84-day review. The FDA summary names no predicate by number. 14 later devices descend from it.

Decided: Oct 3, 2002
Review: 84 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK022234 Arthrex Wrist Bio-Anchor, Model AR-1322BArthrex, Inc. · 2002
Descendant · cites it directly · 12 of its ownK030995 Minilok Quickanchor PlusMitek Worldwide · 2003
Descendant · 2 generations on · 8 of its ownK071257 Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007
Descendant · 3 generations on · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
Descendant · 3 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
Descendant · 2 generations on · 1 of its ownK153585 Flip Button Suture AnchorFirst Ray, LLC · 2016

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003high 2 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 14 · See all

K030995Minilok Quickanchor PlusMitek Worldwide · 2003 · cites it directly12descendants
K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007 · 2 generations on8descendants
K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · 3 generations on1descendant
K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 3 generations on1descendant
K153585Flip Button Suture AnchorFirst Ray, LLC · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022234	Arthrex Wrist Bio-Anchor, Model AR-1322B	Arthrex, Inc.	2002	—
+1	K030995	Minilok Quickanchor Plus	Mitek Worldwide	2003	—
+2	K071257	Mini Quickanchor and Quickanchor Plus with Orthocord	Depuy Mitek, A Johnson & Johnson Company	2007	—
+3	K212381	VersaTap, VersaLat, DueLock, VersaTi, MiniTi	Ortho-Design (Pty), Ltd.	2021	—
+3	K201636	Hercules Suture Anchor System	In2bones USA, LLC	2020	—
+2	K153585	Flip Button Suture Anchor	First Ray, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2007	1	0
2012	2	0
2013	2	0
2015	1	0
2016	1	0
2020	1	0
2021	1	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K022234, 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K030995	Minilok Quickanchor Plus	Mitek Worldwide	2003	12
K050634	Modification to: Arthrex V-Tak	Arthrex, Inc.	2005	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?

Of its descendants, K030995 (Mitek Worldwide, 2003) has gone furthest, with 12 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Arthrex Mini Bio-Anchor is a bioabsorbable polylactide (PLDLA) screw intended to provide fixation of suture to bone in surgeries of the foot, ankle, elbow, and hand/wrist. Specifically;

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Foot: Hallux Valgus reconstruction

Ankle: Mid-foot reconstruction

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022234 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022234: Arthrex Wrist Bio-Anchor, Model AR-1322B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022234

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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