K242356 is an FDA 510(k) clearance for the TIDAL Fusion Cage System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3020. 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..
| 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 |
| 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. |