Cleared Traditional

XT3 System

K241357 · Biodynamik, Inc. · Orthopedic

Jan 2025

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K241357 is an FDA 510(k) clearance for the XT3 System, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Biodynamik, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 22, 2025, 253 days after receiving the submission on May 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K241357 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2024
Decision Date	January 22, 2025
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF