I.T.S. Clavicle Plates with Angular Stability +11 more— 510(k) K260958

Name: FDA 510(k) clearance K260958
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

I.T.S. GmbH

FDA 510(k) clearance K260958 for I.T.S. Clavicle Plates with Angular Stability +11 more, Substantially Equivalent on 2026-06-16. Applicant: I.T.S. GmbH. Device class: 2.

Summary

I.T.S. GmbH's clearance is filed under HRS, bone fixation plates. The device name lists 12 I.T.S. entries, most of them plates with angular stability, along with a screw system, a sacral rod system, and a calcaneus repair system. It breaks off mid-entry at "I.T.S. LRS (L", so the full list isn't in the record.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

I.T.S. filed from Laßnitzhöhe, Austria. The decision came 85 calendar days after FDA received it (March 23 to June 16, 2026).

Clearance details

Device name as filed: 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
Applicant: I.T.S. GmbH
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-03-23
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laßnitzhöhe, AT

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.