Cleared Special

Iconix Speed Anchor; Iconix Speed HA+ Anchor

K252144 · Riverpoint Medical · Orthopedic
Jul 2025
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K252144 is an FDA 510(k) clearance for the Iconix Speed Anchor; Iconix Speed HA+ Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on July 30, 2025, 22 days after receiving the submission on July 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252144 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2025
Decision Date July 30, 2025
Days to Decision 22 days
Submission Type Special
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