TIDAL Fusion Cage System
FDA 510(k) K242356 · Restor3D, Inc.
510(k) numberK242356
Submission
- Device name
- TIDAL Fusion Cage System
- Applicant
- Restor3D, Inc.
Durham, NC, US - Received
- August 8, 2024
- Decision date
- March 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SAI – Ankle Fusion Cage
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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.
Other 510(k)s with product code SAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230088 | Ankle Truss System (ATS)SAI · Traditional | 4Web Medical, Inc. | 03/21/2024SE |
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| K252067 | Velora Acetabular SystemLPH · Traditional | 12/05/2025SE |
| K252454 | Kinos Total Ankle SystemHSN · Special | 09/03/2025SE |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty SystemPHX · Traditional | 05/19/2025SE |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement SystemMBH · Traditional | 03/27/2025SE |
| K242868 | Kinos Total Ankle SystemHSN · Special | 10/18/2024SE |
| K241482 | Kinos Total Ankle SystemHSN · Traditional | 07/22/2024SE |
| K240591 | restor3d Kinos Axiom Total Ankle SystemHSN · Traditional | 04/29/2024SE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion SystemMAX · Special | 01/22/2024SE |
Questions and answers
When was TIDAL Fusion Cage System cleared by the FDA?
TIDAL Fusion Cage System (K242356) received a 510(k) decision of Substantially Equivalent on March 24, 2025, 228 days after the submission was received.
What is the product code of K242356?
The FDA product code is SAI – Ankle Fusion Cage, a Class II (moderate risk) device regulated under 21 CFR 888.3020.