K230088 is an FDA 510(k) clearance for the Ankle Truss System (ATS). This device is classified as a Ankle Fusion Cage (Class II - Special Controls, product code SAI).
Submitted by 4Web Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on March 21, 2024, 434 days after receiving the submission on January 12, 2023.
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 | K230088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2023 |
| Decision Date | March 21, 2024 |
| Days to Decision | 434 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. |