510(k) · Cleared

Cleared

Aap Radius Set 2.5

K123875510(k) TraditionalCleared Mar 11, 201384-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

Aap Implantate AG · HRS Plate, Fixation, Bone

Cleared on Mar 11, 2013 as substantially equivalent to K012114 (Synthes (Usa), 2001) after an 84-day review. Its family tree reaches back 1 generation to 2001. 21 later devices descend from it.

Decided: Mar 11, 2013
Review: 84 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K012114 (2001). 21 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK012114 Synthes Locking Distal Radius Plating SystemSynthes (Usa) · 2001 · Recalled
This deviceK123875 Aap Radius Set 2.5Aap Implantate AG · 2013
Descendant · cites it directly · 20 of its ownK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
Descendant · 2 generations on · 11 of its ownK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
Descendant · 2 generations on · 6 of its ownK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
Descendant · 2 generations on · 2 of its ownK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
Descendant · 3 generations on · 1 of its ownK254215 Arthrex Beaming SystemArthrex, Inc. · 2026

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2013high 7 (2026) · low 0 (2014)2026

Most influential descendants

Showing 5 of 21 · See all

K131474Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013 · cites it directly20descendants
K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · 2 generations on11descendants
K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015 · 2 generations on6descendants
K143749Arthrex Distal Radius SystemArthrex, Inc. · 2015 · 2 generations on2descendants
K254215Arthrex Beaming SystemArthrex, Inc. · 2026 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012114	Synthes Locking Distal Radius Plating System	Synthes (Usa)	2001	3
0 (this device)	K123875	Aap Radius Set 2.5	Aap Implantate AG	2013	—
+1	K131474	Arthrex Distal Radius Plate System	Arthrex, Inc.	2013	—
+2	K201132	Arthrex Compression Screws	Arthrex, Inc.	2020	—
+2	K150456	Arthrex Plates, Screws, and Staples	Arthrex, Inc.	2015	—
+2	K143749	Arthrex Distal Radius System	Arthrex, Inc.	2015	—
+3	K254215	Arthrex Beaming System	Arthrex, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	2	0
2019	1	0
2020	1	0
2021	1	0
2022	3	0
2024	2	0
2025	3	0
2026	7	0

FIG. 1 — Lineage of K123875, 2001–2026Source: 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

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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
*	K012114	Synthes Locking Distal Radius Plating System Summary page 1 …C: Screw, Fixation, Bone Predicate device: Synthes Locking Distal Radius Plating System, Synthes (USA) with premarket notification no. K012114 (SEP 28, 2001). Device Description: Bone plates and screws are used for fixation of bone fragments,…	Synthes (Usa)	2001	3

Also cleared against K012114: 15 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K131474	Arthrex Distal Radius Plate System	Arthrex, Inc.	2013	20

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 a recall.
Of its descendants, K131474 (Arthrex, Inc., 2013) has gone furthest, with 20 descendants of its own.
15 other devices also cite its predicate K012114.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 aap Radius Set 2.5 is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123875 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123875: Aap Radius Set 2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123875

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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