Cleared Traditional

LigaMend

K253695 · Riverpoint Medical, LLC · Orthopedic
Feb 2026
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K253695 is an FDA 510(k) clearance for the LigaMend, 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 February 27, 2026, 98 days after receiving the submission on November 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K253695 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2025
Decision Date February 27, 2026
Days to Decision 98 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