510(k) · Cleared

Recalled · Class II · 2026

Humeral Head Plate with Angular Stability

K051412510(k) TraditionalCleared Jul 11, 200541-day reviewClass II21 CFR 888.3030Recalls 1

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

I.T.S. Implantat-Technologie-Systeme GmbH · HRS Plate, Fixation, Bone

Cleared on Jul 11, 2005 as substantially equivalent to K041860 (Synthes (Usa), 2004) and 5 other predicates after a 41-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it. It has been recalled once.

Decided: Jul 11, 2005
Review: 41 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 6

Its longest line of descent runs back 2 generations to K983853 (1998). 10 ancestors in all, the oldest K955472 (1996). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK983853 Depuy Ace Timax Meta PlateDepuy Ace Medical Co. · 1998
1 generation backK041965 Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc. · 2004
This deviceK051412 Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2005
Descendant · cites it directly · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
Descendant · cites it directly · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all

K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · cites it directly0descendants
K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K983853	Depuy Ace Timax Meta Plate	Depuy Ace Medical Co.	1998	—
−1	K041965	Arthrex Humeral Fracture Plates and Screws	Arthrex, Inc.	2004	—
0 (this device)	K051412	Humeral Head Plate with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2005	—
+1	K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with…	I.T.S. GmbH	2026	—
+1	K223933	Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws	Exactech, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2001	3	0
2003	2	0
2004	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0
2026	1	0

FIG. 1 — Lineage of K051412, 1998–2026Source: 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? (6)

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
*	K041860	Synthes (Usa) LCP Proximal Humerus Plates, Long Summary page 1 …Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HRKS SUBSTANTIALLY Synthes LCP Proximal Humerus Plates (K041860 & K011815) EQUIVALENT DEVICES Hand Innovations Shoulder Fixation System (K042059) Arthrex Humeral…	Synthes (Usa)	2004	—
*	K011815	Synthes LCP Proximal Humerus Plates Summary page 1 …Fixation, Bone (see 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HRKS SUBSTANTIALLY Synthes LCP Proximal Humerus Plates (K041860 & K011815) EQUIVALENT DEVICES Hand Innovations Shoulder Fixation System (K042059) Arthrex Humeral Fracture P…	Synthes (Usa)	2001	—
*	K042059	Shoulder Fixation System Summary page 1 …PRODUCT CODE: HRKS SUBSTANTIALLY Synthes LCP Proximal Humerus Plates (K041860 & K011815) EQUIVALENT DEVICES Hand Innovations Shoulder Fixation System (K042059) Arthrex Humeral Fracture Plates and Screws (K041965) DePuy ACE TIMAX® Meta Pla…	Hand Innovations, Inc.	2004	—
*	K041965	Arthrex Humeral Fracture Plates and Screws Summary page 1 …tes (K041860 & K011815) EQUIVALENT DEVICES Hand Innovations Shoulder Fixation System (K042059) Arthrex Humeral Fracture Plates and Screws (K041965) DePuy ACE TIMAX® Meta Plate (K983853) ACE Humerus & Radius Plates (K955472) D…	Arthrex, Inc.	2004	—
*	K983853	Depuy Ace Timax Meta Plate Summary page 1 …ns Shoulder Fixation System (K042059) Arthrex Humeral Fracture Plates and Screws (K041965) DePuy ACE TIMAX® Meta Plate (K983853) ACE Humerus & Radius Plates (K955472) DEVICE DESCRIPTION: The IT.S. Humeral Head Plate with Angul…	Depuy Ace Medical Co.	1998	—
*	K955472	Ace Humerus & Radius Plates Summary page 1 …Arthrex Humeral Fracture Plates and Screws (K041965) DePuy ACE TIMAX® Meta Plate (K983853) ACE Humerus & Radius Plates (K955472) DEVICE DESCRIPTION: The IT.S. Humeral Head Plate with Angular Stability is a low- profile univers…	Ace Medical Co.	1996	—

Also cleared against K041860: 35 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
K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…	I.T.S. GmbH	2026	0
K223933	Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws	Exactech, Inc.	2023	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 23, 2026	Class II	Z-1594-2026	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
None of the 10 ancestors has a recall.
Of its descendants, K260958 (I.T.S. GmbH, 2026) has gone furthest, with 0 descendants of its own.
35 other devices also cite its predicate K041860.

How does its category compare?

All HRS devices

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

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 I.T.S. Humeral Head Plate with Angular Stability is a titanium implant

fracture fixation system for stabilizing fractures of the proximal humerus

in the shoulder.

Indications for Use include fracture and fracture dislocations,

osteotomies, and non-unions of the proximal humerus, particularly in

osteopenic bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051412 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051412: Humeral Head Plate with Angular Stability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051412

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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