Cleared Traditional

Strut Suture; No-Tie Button

K253693 · Riverpoint Medical, LLC · Orthopedic

Mar 2026

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K253693 is an FDA 510(k) clearance for the Strut Suture; No-Tie Button, 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 11, 2026, 110 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	K253693 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2025
Decision Date	March 11, 2026
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF