510(k) · Cleared

Recalled · Class II · 2026

Claviculaplate with Angular Stablity Bone Plate System

K050852510(k) TraditionalCleared Jun 22, 200579-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 Jun 22, 2005 as substantially equivalent to K011334 (Synthes (Usa), 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 2000. 38 later devices descend from it. It has been recalled once.

Decided: Jun 22, 2005
Review: 79 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 3

Its longest line of descent runs back 3 generations to K000684 (2000). 8 ancestors in all, the oldest K890939 (1989). 38 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
2 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
1 generation backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
This deviceK050852 Claviculaplate with Angular Stablity Bone Plate SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2005
Descendant · cites it directly · 27 of its ownK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
Descendant · cites it directly · 9 of its ownK100944 Clavicle Locking Plate SystemNewclip Technics · 2010
Descendant · 2 generations on · 9 of its ownK063166 I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
Descendant · 2 generations on · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2006high 6 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 38 · See all

K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · cites it directly27descendants
K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants
K100944Clavicle Locking Plate SystemNewclip Technics · 2010 · cites it directly9descendants
K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · 2 generations on9descendants
K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−2	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−1	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
0 (this device)	K050852	Claviculaplate with Angular Stablity Bone Plate System	I.T.S. Implantat-Technologie-Systeme GmbH	2005	—
+1	K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
+2	K150693	PHIN-FX Cannulated Lag Screw System	Ascent Medical, LLC	2015	—
+1	K100944	Clavicle Locking Plate System	Newclip Technics	2010	—
+2	K063166	I.T.S. Pelvic Reconstruction System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
+2	K110895	Ortho Solutions Trauma Implants for Osteosynthesis	Ortho Solutions Limited	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2010	2	0
2011	2	0
2012	1	0
2013	2	0
2014	1	0
2015	3	0
2016	1	0
2017	5	0
2020	2	0
2021	2	0
2022	4	0
2023	3	0
2024	1	0
2025	1	0
2026	6	0

FIG. 1 — Lineage of K050852, 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K011334	Synthes Curved Reconstruction Plate	Synthes (Usa)	2001	—
Kept off the family tree	K010335	FDA’s K010335 is Slendertone Flex, Model, 512 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Bio-Medical Research, Ltd.	2001	—
*	K012655	Congruent Bone Plate System Summary page 1 …Curved Reconstruction Plate (KOI 1334) EQUIVALENT DEVICES Synthes One -Third Tubular DCL Plate (K1011335) Acumed Clavicle/Congruent Plate (K012655) Synthes Hook Plate DEVICE DESCRIPTION: The I.T.S. Claviculaplate with Angular Stability is a low-…	Acu Med, Inc.	2001	16
*	—	Synthes Hook Plate Named without a submission number			—

Also cleared against K011334: 4 other devices →

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	27
K100944	Clavicle Locking Plate System	Newclip Technics	2010	9
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-1593-2026	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 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
4 of the 8 ancestors have a recall of any class.
Of its descendants, K060156 (I.T.S. Implantat-Technologie-Systeme GmbH, 2006) has gone furthest, with 27 descendants of its own.
4 other devices also cite its predicate K011334.

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. Claviculatplate with Angular Stability is a titanium implant

fracture fixation system for repairing fractures located from the middle

third to the distal third of the clavicle.

Indications for Use include metaphysial and diaphysial fracture fixation of

acute fractures, malunions, and non-unions of the clavicle. Other

indications include corrective osteotomy and open and closed fractures.

The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050852 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050852: Claviculaplate with Angular Stablity Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050852

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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