510(k) · Cleared

Recalled · Class II · 2026

Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking

K130008510(k) TraditionalCleared Jun 25, 2013174-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. GmbH · HRS Plate, Fixation, Bone

Cleared on Jun 25, 2013 as substantially equivalent to K103332 (Medartis AG, 2011) and 7 other predicates after a 174-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it. It has been recalled once.

Decided: Jun 25, 2013
Review: 174 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 8

Its longest line of descent runs back 8 generations to K962616 (1996). 64 ancestors in all, the oldest K885250 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
1 generation backK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
This deviceK130008 Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol)…I.T.S. GmbH · 2013
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
−8	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−7	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−6	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−5	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−4	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−3	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−2	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−1	K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2
0 (this device)	K130008	Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0…	I.T.S. GmbH	2013	—
+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
1989	2	0
1990	1	0
1991	1	0
1992	1	0
1995	2	0
1996	4	0
1998	3	0
1999	2	0
2000	7	0
2001	6	0
2002	1	0
2003	2	0
2004	8	0
2005	6	0
2006	1	0
2007	2	0
2008	2	0
2009	1	0
2011	2	0
2012	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K130008, 1996–2026Source: 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? (8)

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
*	K103332	Aptus Ulna Plates Summary page 1 …nces and accessories. (see 21 CRF, Sec. 888.3030 & Sec. 888.3040). DEVICE PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: HWC SUBSTANTIALLY Medartis AG — APTUS Ulna Plates (K103332) EQUIVALENT DEVICES Zimmer ~ Periarticular Ulna Plate Systems (K082078) Acuimed - Congruent System Acu-Loc 2 Plate (K120903 & K…	Medartis AG	2011	—
*	K082078	Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates Summary page 1 …CE PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: HWC SUBSTANTIALLY Medartis AG — APTUS Ulna Plates (K103332) EQUIVALENT DEVICES Zimmer ~ Periarticular Ulna Plate Systems (K082078) Acuimed - Congruent System Acu-Loc 2 Plate (K120903 & K071715) TriMed - Ulnar Osteotomy Plate (K043263) _ Synthes - 2.7mm LCP Ul…	Zimmer, Inc.	2008	7
*	K120903	Congruent Bone Plate System: Acu-Loc 2 Plate Summary page 1 …STANTIALLY Medartis AG — APTUS Ulna Plates (K103332) EQUIVALENT DEVICES Zimmer ~ Periarticular Ulna Plate Systems (K082078) Acuimed - Congruent System Acu-Loc 2 Plate (K120903 & K071715) TriMed - Ulnar Osteotomy Plate (K043263) _ Synthes - 2.7mm LCP Ulna Osteotomy System (K113364) .OrthoPro - DC Ulnar Sh…	Acumed, LLC	2012	—
*	K071715	Acumed Congruent Bone Plate System Summary page 1 …Medartis AG — APTUS Ulna Plates (K103332) EQUIVALENT DEVICES Zimmer ~ Periarticular Ulna Plate Systems (K082078) Acuimed - Congruent System Acu-Loc 2 Plate (K120903 & K071715) TriMed - Ulnar Osteotomy Plate (K043263) _ Synthes - 2.7mm LCP Ulna Osteotomy System (K113364) .OrthoPro - DC Ulnar Shortening S…	Acumed, LLC	2007	—
*	K043263	Trimed Osteotomy Plate Summary page 1 …) EQUIVALENT DEVICES Zimmer ~ Periarticular Ulna Plate Systems (K082078) Acuimed - Congruent System Acu-Loc 2 Plate (K120903 & K071715) TriMed - Ulnar Osteotomy Plate (K043263) _ Synthes - 2.7mm LCP Ulna Osteotomy System (K113364) .OrthoPro - DC Ulnar Shortening System (K073228) LT.S. GmbH - Straight Pla…	TriMed, Inc.	2005	1
*	K113364	2.7MM LCP Ulna Osteotomy System Summary page 1 …te Systems (K082078) Acuimed - Congruent System Acu-Loc 2 Plate (K120903 & K071715) TriMed - Ulnar Osteotomy Plate (K043263) _ Synthes - 2.7mm LCP Ulna Osteotomy System (K113364) .OrthoPro - DC Ulnar Shortening System (K073228) LT.S. GmbH - Straight Plate w/Angular Stability (K060156) DEVICE DESCRIPTION:…	Synthes (USA) Products, LLC	2012	1
*	K073228	DC Ulnar Shortening System Summary page 1 …cu-Loc 2 Plate (K120903 & K071715) TriMed - Ulnar Osteotomy Plate (K043263) _ Synthes - 2.7mm LCP Ulna Osteotomy System (K113364) .OrthoPro - DC Ulnar Shortening System (K073228) LT.S. GmbH - Straight Plate w/Angular Stability (K060156) DEVICE DESCRIPTION: The LT.S. Ulna Locking Plates are composed of th…	Orthopro, LLC	2008	—
*	K060156	Straight Plate with Angular Stability & Screw System Summary page 1 …y Plate (K043263) _ Synthes - 2.7mm LCP Ulna Osteotomy System (K113364) .OrthoPro - DC Ulnar Shortening System (K073228) LT.S. GmbH - Straight Plate w/Angular Stability (K060156) DEVICE DESCRIPTION: The LT.S. Ulna Locking Plates are composed of the DUL (Distal Ulna Locking) & UOL (Ulna Osteotomy Locking)…	I.T.S. Implantat-Technologie-Systeme GmbH	2006	2

Also cleared against K103332: 11 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-1604-2026	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 17 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
23 of the 64 ancestors have a recall of any class.
Of its descendants, K260958 (I.T.S. GmbH, 2026) has gone furthest, with 0 descendants of its own.
11 other devices also cite its predicate K103332.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Indications for Use of the L.T.S. GmbH - Distal Ulna Locking (DUL) and Ulna Osteotomy Locking (UOL) Plate Systems is to stabilize fractures/osteotomy in the long bone of the distal and mid-ulna of an adult patient.

The L.T.S. GmbH — Ulna Locking Plate (DUL & UOL) Systems are not intended for spinal use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K130008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130008

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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