Cleared Traditional

Arthrex SpeedFLEX? Implant

K251690 · Arthrex, Inc. · Orthopedic

Sep 2025

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K251690 is an FDA 510(k) clearance for the Arthrex SpeedFLEX? Implant, a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWY), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 30, 2025, 120 days after receiving the submission on June 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K251690 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2025
Decision Date	September 30, 2025
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWY — Mesh, Surgical, Collagen, 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.