Cleared Traditional

RootMend MRR

K243988 · Riverpoint Medical, LLC · Orthopedic
Mar 2025
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K243988 is an FDA 510(k) clearance for the RootMend MRR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on March 20, 2025, 84 days after receiving the submission on December 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K243988 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2024
Decision Date March 20, 2025
Days to Decision 84 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