Cleared Traditional

The Response Ortho Smart Fixator - Hexapod System

K252625 · Response Ortho Solutions, LLC · Orthopedic

Nov 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K252625 is an FDA 510(k) clearance for the The Response Ortho Smart Fixator - Hexapod System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Response Ortho Solutions, LLC (Boca Raton, US). The FDA issued a Cleared decision on November 20, 2025, 93 days after receiving the submission on August 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252625 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2025
Decision Date	November 20, 2025
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030