Cleared Traditional

I.T.S. Clavicle Plates with Angular Stability (K260958) - FDA 510(k) Clearance

Also marketed or referenced as:
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

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260958 · I.T.S. GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
85d
Days
Class 2
Risk

K260958 is an FDA 510(k) clearance for the I.T.S. Clavicle Plates with Angular Stability. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by I.T.S. GmbH (Laßnitzhöhe, AT). The FDA issued a Cleared decision on June 16, 2026 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.T.S. GmbH devices

Submission Details

510(k) Number K260958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2026
Decision Date June 16, 2026
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 700
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