510(k) · Cleared

Recalled · Class II · 2026

Distal Humeral Plates with Angular Stability

K080184510(k) TraditionalCleared Mar 26, 200861-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 Mar 26, 2008 as substantially equivalent to K033995 (Synthes (Usa), 2004) and 4 other predicates after a 61-day review. Its family tree reaches back 4 generations to 2000. 15 later devices descend from it. It has been recalled once.

Decided: Mar 26, 2008
Review: 61 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 5

Its longest line of descent runs back 4 generations to K000684 (2000). 16 ancestors in all, the oldest K890939 (1989). 15 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
1 generation backK063460 Acumed Congruent Bone Plate SystemAcumed, LLC · 2006
This deviceK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008
Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Descendant · 2 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
Descendant · cites it directly · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
Descendant · 3 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2014high 4 (2026) · low 0 (2015)2026

Most influential descendants

Showing 5 of 15 · See all

K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 2 generations on3descendants
K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · cites it directly3descendants
K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−3	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−2	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
−1	K063460	Acumed Congruent Bone Plate System	Acumed, LLC	2006	—
0 (this device)	K080184	Distal Humeral Plates with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2008	—
+1	K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…	I.T.S. GmbH	2014	—
+2	K161327	Syntec Humeral Nail System	Syntec Scientific Corporation	2017	—
+1	K161894	SurgTech Trauma System	Surgtech, Inc.	2017	—
+2	K242939	ARTFX Trauma Bone Plate and Screw System	Artfx Medical	2024	—
+3	K181296	Syntec Femoral Nail System	Syntec Scientific Corporation	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
1996	2	0
1998	1	0
2000	1	0
2001	2	0
2004	2	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2017	3	0
2019	2	0
2020	1	0
2023	1	0
2024	1	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K080184, 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? (5)

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
*	K033995	3.5 MM LCP Distal Humerus System Summary page 1 …one (see 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HRS SUBSTANTIALLY Synthes 3.5mm LCP Distal Humerus System (K033995) EQUIVALENT DEVICES Acumed Congruent Bone Plate System (K012655), (K063460), (K071715)…	Synthes (Usa)	2004	1
*	K012655	Congruent Bone Plate System Summary page 1 …DUCT CODE: HRS SUBSTANTIALLY Synthes 3.5mm LCP Distal Humerus System (K033995) EQUIVALENT DEVICES Acumed Congruent Bone Plate System (K012655), (K063460), (K071715) Zimmer Periarticular Locking Plates and Screws (K040593)…	Acu Med, Inc.	2001	16
*	K063460	Acumed Congruent Bone Plate System Summary page 1 …HRS SUBSTANTIALLY Synthes 3.5mm LCP Distal Humerus System (K033995) EQUIVALENT DEVICES Acumed Congruent Bone Plate System (K012655), (K063460), (K071715) Zimmer Periarticular Locking Plates and Screws (K040593) DEVICE DE…	Acumed, LLC	2006	—
*	K071715	Acumed Congruent Bone Plate System Summary page 1 …Synthes 3.5mm LCP Distal Humerus System (K033995) EQUIVALENT DEVICES Acumed Congruent Bone Plate System (K012655), (K063460), (K071715) Zimmer Periarticular Locking Plates and Screws (K040593) DEVICE DESCRIPTION: The I.T.S. GmbH Dist…	Acumed, LLC	2007	—
*	K040593	Periarticular Locking Plates and Screws, 2358, 2359 Series Summary page 1 …Acumed Congruent Bone Plate System (K012655), (K063460), (K071715) Zimmer Periarticular Locking Plates and Screws (K040593) DEVICE DESCRIPTION: The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a fracture fi…	Zimmer, Inc.	2004	2

Also cleared against K033995: 23 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail	I.T.S. GmbH	2014	10
K161894	SurgTech Trauma System	Surgtech, Inc.	2017	3
K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…	I.T.S. GmbH	2026	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-1602-2026	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 8 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
7 of the 16 ancestors have a recall of any class.
Of its descendants, K132945 (I.T.S. GmbH, 2014) has gone furthest, with 10 descendants of its own.
23 other devices also cite its predicate K033995.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.

Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080184 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080184: Distal Humeral Plates with Angular Stability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080184

Report an extraction error

Are you the manufacturer?

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