Cleared Traditional

TIDAL Fusion Cage System

K242356 · Restor3D, Inc. · Orthopedic

Mar 2025

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K242356 is an FDA 510(k) clearance for the TIDAL Fusion Cage System, a Ankle Fusion Cage (Class II — Special Controls, product code SAI), submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on March 24, 2025, 228 days after receiving the submission on August 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K242356 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2024
Decision Date	March 24, 2025
Days to Decision	228 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	SAI — Ankle Fusion Cage
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3020
Definition	Intended For Use As An Accessory To A Tibiotalocalcaneal Intramedullary (im) Rod As Part Of A Fusion Construct For Failed Ankle Arthrodesis Or Failed Ankle Arthroplasty. Not Intended For Standalone Use.