Cleared Traditional

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

K243344 · Arthrex, Inc. · Orthopedic

Feb 2025

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K243344 is an FDA 510(k) clearance for the Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 20, 2025, 118 days after receiving the submission on October 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K243344 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2024
Decision Date	February 20, 2025
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF