# K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Jun 25, 2013 after 174 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962616 (1996). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 1.
- K082078: Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates, Zimmer, Inc. (2008) Summary page 1.
- K120903: Congruent Bone Plate System: Acu-Loc 2 Plate, Acumed, LLC (2012) Summary page 1.
- K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) Summary page 1.
- K043263: Trimed Osteotomy Plate, TriMed, Inc. (2005) Summary page 1.
- K113364: 2.7MM LCP Ulna Osteotomy System, Synthes (USA) Products, LLC (2012) Summary page 1.
- K073228: DC Ulnar Shortening System, Orthopro, LLC (2008) Summary page 1.
- K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 1.

## Most influential descendants
- K260958: I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (2026), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1604-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

## Indications for use
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.

Source page: https://510kreport.com/device/K130008
Methodology: https://510kreport.com/methodology