# K142418: I.T.S. Hand Locking Plates System - HLS

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Sep 26, 2014 after 29 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: 11 generations back to K962616 (1996). 157 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 4.
- K060613: Variax Locking Plate System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 4.
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 4.
- K061748: Fragment Plate System, Hand Innovations, LLC (2006) Summary page 4.
- K041081: Fragment Plate System, Screws, Pins and K-Wires, Hand Innovations, Inc. (2004) Summary page 4.
- K131722: I.T.S. Extremity Fixation Systems, I.T.S. GmbH (2013) Summary page 4.

## 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-1607-2026: 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 intended use of the I.T.S. Hand Locking Plates System — HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient. The I.T.S. Hand Locking Plates System — HLS is indicated for use in fracture fixation of: the phalanges, the metacarpal bones, the carpal bones, for arthrodesis, for corrective osteotomies, and for subcapital radial head fractures. The I.T.S. Hand Locking Plates System is not for spinal use.

Source page: https://510kreport.com/device/K142418
Methodology: https://510kreport.com/methodology