Ankle Truss System (ATS)
FDA 510(k) K230088 · 4Web Medical, Inc.
510(k) numberK230088
Submission
- Device name
- Ankle Truss System (ATS)
- Applicant
- 4Web Medical, Inc.
Frisco, TX, US - Received
- January 12, 2023
- Decision date
- March 21, 2024
- 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 |
|---|---|---|---|
| K242356 | TIDAL Fusion Cage SystemSAI · Traditional | Restor3D, Inc. | 03/24/2025SE |
More from Restor3D, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 01/28/2026SE |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE · Traditional | 12/11/2025SE |
| K251117 | Cervical Spine Truss System (CSTS)OVE · Special | 04/25/2025SE |
| K240388 | Osteotomy Truss System (OTS)HRS · Traditional | 11/01/2024SE |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD · Traditional | 04/22/2024SE |
| K231739 | Cervical Spine Truss System (CSTS)OVE · Traditional | 09/25/2023SE |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE · Traditional | 02/02/2023SE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/05/2023SE |
| K221283 | Hammertoe Truss System (HTS)HTY · Traditional | 09/06/2022SE |
| K220463 | Osteotomy Truss System (OTS)HRS · Traditional | 05/18/2022SE |
Questions and answers
When was Ankle Truss System (ATS) cleared by the FDA?
Ankle Truss System (ATS) (K230088) received a 510(k) decision of Substantially Equivalent on March 21, 2024, 434 days after the submission was received.
What is the product code of K230088?
The FDA product code is SAI – Ankle Fusion Cage, a Class II (moderate risk) device regulated under 21 CFR 888.3020.