510(k) · Cleared

Cleared

Aptus 2.0 Radial Head System

K090053510(k) TraditionalCleared Apr 23, 2009105-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

Medartis AG · HRS Plate, Fixation, Bone

Cleared on Apr 23, 2009 after a 105-day review. The FDA summary names no predicate by number. 8 later devices descend from it.

Decided: Apr 23, 2009
Review: 105 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

8 later devices descend from it, 3 citing it directly.

This deviceK090053 Aptus 2.0 Radial Head SystemMedartis AG · 2009
Descendant · cites it directly · 5 of its ownK130774 Universal Distal Radius SystemNewclip Technics · 2013
Descendant · 2 generations on · 2 of its ownK142502 Alians Ulna Locking Plating SystemNewclip Technics · 2014
Descendant · 3 generations on · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
Descendant · 2 generations on · 1 of its ownK170843 Alians Fragment SpecificNewclip Technics · 2017
Descendant · 4 generations on · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2013high 2 (2021) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all

K130774Universal Distal Radius SystemNewclip Technics · 2013 · cites it directly5descendants
K142502Alians Ulna Locking Plating SystemNewclip Technics · 2014 · 2 generations on2descendants
K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · 3 generations on1descendant
K170843Alians Fragment SpecificNewclip Technics · 2017 · 2 generations on1descendant
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K090053	Aptus 2.0 Radial Head System	Medartis AG	2009	—
+1	K130774	Universal Distal Radius System	Newclip Technics	2013	—
+2	K142502	Alians Ulna Locking Plating System	Newclip Technics	2014	—
+3	K211592	Avanti Orthopaedics Ulnar Shortening System	Avanti Orthopaedics, Inc.	2021	—
+2	K170843	Alians Fragment Specific	Newclip Technics	2017	—
+4	K261145	Avanti Distal Elbow ORIF System	Avanti Orthopaedics, LLC	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2017	1	0
2020	1	0
2021	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K090053, 2009–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K130774	Universal Distal Radius System	Newclip Technics	2013	5
K243469	Signex	Osteonic Co., Ltd.	2025	0
K201656	ARIX Elbow System	Jeil Medical Corporation	2020	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, K130774 (Newclip Technics, 2013) has gone furthest, with 5 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 APTUS ® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090053 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090053: Aptus 2.0 Radial Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090053

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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