Cleared Traditional

Biomet Kirschner Wires (K-Wires)

K241014 · Biomet, Inc. · Orthopedic
May 2024
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K241014 is an FDA 510(k) clearance for the Biomet Kirschner Wires (K-Wires), a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 22, 2024, 40 days after receiving the submission on April 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241014 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2024
Decision Date May 22, 2024
Days to Decision 40 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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