Cleared Special

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

K260073 · Biodynamik, Inc. · Orthopedic

Feb 2026

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K260073 is an FDA 510(k) clearance for the XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm, 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 February 10, 2026, 32 days after receiving the submission on January 9, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K260073 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 2026
Decision Date	February 10, 2026
Days to Decision	32 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF