Cleared Special

Cannulated Screw and Kirschner (K wire) System

K252758 · Orthonovis, Inc. · Orthopedic
Oct 2025
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K252758 is an FDA 510(k) clearance for the Cannulated Screw and Kirschner (K wire) System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Orthonovis, Inc. (Palm Coast, US). The FDA issued a Cleared decision on October 2, 2025, 34 days after receiving the submission on August 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252758 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2025
Decision Date October 02, 2025
Days to Decision 34 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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