510(k) · Cleared

Cleared

Arthrex Distal Radius System

K143749510(k) TraditionalCleared Apr 3, 201593-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. · HRS Plate, Fixation, Bone

Cleared on Apr 3, 2015 as substantially equivalent to K082300 (DePuy Orthopaedics, Inc., 2009) and 3 other predicates after a 93-day review. Its family tree reaches back 9 generations to 2000. 2 later devices descend from it.

Decided: Apr 3, 2015
Review: 93 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 9 generations to K000684 (2000). 50 ancestors in all, the oldest K885250 (1989). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
5 generations between
3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
1 generation backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
This deviceK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
Descendant · cites it directly · 0 of its ownK254162 KLS Martin Ixos SystemKLS Martin L.P. · 2026
Descendant · cites it directly · 0 of its ownK220244 DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · 2022

Show all 9 generations

Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
8 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
7 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
6 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
5 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
4 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
1 generation backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
This deviceK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K254162KLS Martin Ixos SystemKLS Martin L.P. · 2026 · cites it directly0descendants
K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−8	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−7	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
−6	K021626	Hallu Plates	New Deal, S.A.	2002	—
−5	K040907	Arthrex Small Fragment Plates and Screws	Arthrex, Inc.	2004	—
−4	K052614	Low Profile Plate and Screw System	Arthrex, Inc.	2005	—
−3	K103705	Low Profile Screws	Arthrex, Inc.	2011	—
−2	K111253	Arthrex Distal Extremity Plate System	Arthrex, Inc.	2011	—
−1	K131474	Arthrex Distal Radius Plate System	Arthrex, Inc.	2013	—
0 (this device)	K143749	Arthrex Distal Radius System	Arthrex, Inc.	2015	—
+1	K254162	KLS Martin Ixos System	KLS Martin L.P.	2026	—
+1	K220244	DVR® Crosslock Wrist Spanning Plate (131849181)	Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1991	1	0
1994	1	0
1995	2	0
1996	9	0
1998	2	0
2000	2	0
2001	4	0
2002	4	0
2003	1	0
2004	2	0
2005	2	0
2006	2	0
2007	1	0
2008	1	0
2009	2	0
2010	2	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2026	1	0

FIG. 1 — Lineage of K143749, 2000–2026Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (4)

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
*	K082300	Anatomic Locking Plating System Summary page 4 …andaccessories 21CFR888.3040:Smoothorthreadedmetallicbonefixationfastener PredicateDevice K082300:DePuyOrthopaedicsAnatomicLockingPlatingSystem K081546:DePuyOrthopaedicsSmallBoneLockin…	DePuy Orthopaedics, Inc.	2009	2
*	K081546	Small Bone Locking Plating System Summary page 4 …horthreadedmetallicbonefixationfastener PredicateDevice K082300:DePuyOrthopaedicsAnatomicLockingPlatingSystem K081546:DePuyOrthopaedicsSmallBoneLockingPlatingSystem K131474:ArthrexDistalRadiusPlateSystem…	DePuy Orthopaedics, Inc.	2008	1
*	K131474	Arthrex Distal Radius Plate System Summary page 4 …rthopaedicsAnatomicLockingPlatingSystem K081546:DePuyOrthopaedicsSmallBoneLockingPlatingSystem K131474:ArthrexDistalRadiusPlateSystem K040907:ArthrexSmallFragmentPlatesandScrews Purpose…	Arthrex, Inc.	2013	—
*	K040907	Arthrex Small Fragment Plates and Screws Summary page 4 …K081546:DePuyOrthopaedicsSmallBoneLockingPlatingSystem K131474:ArthrexDistalRadiusPlateSystem K040907:ArthrexSmallFragmentPlatesandScrews PurposeofSubmission Thistraditional510(k)premarketnotificationissubmi…	Arthrex, Inc.	2004	—

Also cleared against K082300: 9 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K254162	KLS Martin Ixos System	KLS Martin L.P.	2026	0
K220244	DVR® Crosslock Wrist Spanning Plate (131849181)	Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech	2022	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?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
16 of the 50 ancestors have a recall of any class.
Of its descendants, K254162 (KLS Martin L.P., 2026) has gone furthest, with 0 descendants of its own.
9 other devices also cite its predicate K082300.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The Arthrex Distal Radius System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143749 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143749: Arthrex Distal Radius System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143749

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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