Cleared Traditional

K242356 - TIDAL Fusion Cage System

K242356 is an FDA 510(k) clearance for TIDAL Fusion Cage System, manufactured by Restor3D, Inc.. The device is a Class 2 Orthopedic device with product code SAI cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K242356 · Restor3D, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
228d
Days
Class 2
Risk

K242356 is an FDA 510(k) clearance for the TIDAL Fusion Cage System. Classified as Ankle Fusion Cage (product code SAI), Class II - Special Controls.

Submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on March 24, 2025 after a review of 228 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Restor3D, Inc. devices

FDA 510(k) Submission Details - K242356

510(k) Number K242356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 122d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SAI Device Classification - Class 2, Special Controls

Product Code SAI Ankle Fusion Cage
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.