Cleared Traditional

Arthrex DynaNite Nitinol Staples

K243742 · Arthrex, Inc. · Orthopedic
Jan 2025
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K243742 is an FDA 510(k) clearance for the Arthrex DynaNite Nitinol Staples, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on January 31, 2025, 58 days after receiving the submission on December 4, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243742 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2024
Decision Date January 31, 2025
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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