510(k) · Cleared

Recalled · Class II · 2026

Pilonplate with Angular Stability

K052011510(k) TraditionalCleared Aug 10, 200516-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 Aug 10, 2005 as substantially equivalent to K020602 (Synthes, 2002) and 4 other predicates after a 16-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.

Decided: Aug 10, 2005
Review: 16 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 5

Its longest line of descent runs back 1 generation to K854825 (1986). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK854825 Link Small Bone PlatesLink America, Inc. · 1986
This deviceK052011 Pilonplate 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

Most influential descendants

Showing 1 of 1 · 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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854825	Link Small Bone Plates	Link America, Inc.	1986	—
0 (this device)	K052011	Pilonplate 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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K052011, 1986–2026Source: 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? (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
*	K020602	Synthes Pilon Plate Summary page 1 …Bone Plate System CLASSIFICATION: Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HIRS SUBSTANTIALLY Synthes Pilon Plate (K020602) EQUIVALENT DEVICES DePuy/Ace TIMAX Pilon Plate (K(982347) Synthes LCP Distal Tibia Plates (1(013248)…	Synthes	2002	—
*	K982347	Depuy Ace Timax Pilon Plate Summary page 1 …one (see 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HIRS SUBSTANTIALLY Synthes Pilon Plate (K020602) EQUIVALENT DEVICES DePuy/Ace TIMAX Pilon Plate (K(982347) Synthes LCP Distal Tibia Plates (1(013248) Synthes (USA) Medial Distal Tibia Plate…	Depuy Ace Medical Co.	1998	—
*	K013248	Synthes LCP Distal Tibia Plates Summary page 1 …STANTIALLY Synthes Pilon Plate (K020602) EQUIVALENT DEVICES DePuy/Ace TIMAX Pilon Plate (K(982347) Synthes LCP Distal Tibia Plates (1(013248) Synthes (USA) Medial Distal Tibia Plates (K(001945) Link Small Bone Plates (May An…	Synthes (Usa)	2001	—
*	K001945	Synthes (Usa) Medial Distal Tibia Plates Summary page 1 …Puy/Ace TIMAX Pilon Plate (K(982347) Synthes LCP Distal Tibia Plates (1(013248) Synthes (USA) Medial Distal Tibia Plates (K(001945) Link Small Bone Plates (May Anatomical Plate) (1K854825) Zimmer Periarticular Plat…	Synthes (Usa)	2000	—
*	K854825	Link Small Bone Plates Summary page 1 …Tibia Plates (1(013248) Synthes (USA) Medial Distal Tibia Plates (K(001945) Link Small Bone Plates (May Anatomical Plate) (1K854825) Zimmer Periarticular Plating System DEVICE DESCRIPTION: The I.T.S. Pilonpiate with Angular Stability…	Link America, Inc.	1986	—
*	—	Zimmer Periarticular Plating System Named without a submission number			—

Also cleared against K020602: 3 other devices →

What descends from it? (1)

1 later device cites 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

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-1596-2026	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?

None of the 5 ancestors has a recall.
Of its descendants, K260958 (I.T.S. GmbH, 2026) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K020602.

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. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg.

Indications for Use include fixation of complex intra- and extra-articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052011 · printed Nov 3, 2026

Cite this page

510(k) Report. “K052011: Pilonplate with Angular Stability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052011

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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