Cleared Traditional

Arthrex PushLock Suture Anchors

K251145 · Arthrex, Inc. · Orthopedic
Jul 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K251145 is an FDA 510(k) clearance for the Arthrex PushLock Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 10, 2025, 87 days after receiving the submission on April 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251145 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2025
Decision Date July 10, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040