Cleared Traditional

SuturePatch Tissue Reinforcement

K243480 · Arthrex, Inc. · Orthopedic
May 2025
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K243480 is an FDA 510(k) clearance for the SuturePatch Tissue Reinforcement, a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWX), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 29, 2025, 202 days after receiving the submission on November 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K243480 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date May 29, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OWX — Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.