FDA product code SAI: Ankle Fusion Cage
SAI is the FDA product code for ankle fusion cage. It is a Class II device, regulated under 21 CFR 888.3020 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under SAI, 2 in the last five years, from 2 different applicants. The average 510(k) review took 331 days (median 331); 331 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ankle Fusion Cage |
| Device class | Class II |
| Regulation | 21 CFR 888.3020 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for SAI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 434 |
| 2025 | 1 | 228 |
Compare with all 510(k) review times · Search every SAI clearance
Top SAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Restor3D, Inc. | 1 | 2025-03-24 |
| 4Web Medical, Inc. | 1 | 2024-03-21 |
Most recent SAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242356 | Restor3D, Inc. | TIDAL Fusion Cage System | 2025-03-24 | 228 |
| K230088 | 4Web Medical, Inc. | Ankle Truss System (ATS) | 2024-03-21 | 434 |
Recalls for SAI devices
openFDA lists no recalls for product code SAI.
Frequently asked questions
What is FDA product code SAI?
SAI is the FDA product code for ankle fusion cage. It is a Class II device, regulated under 21 CFR 888.3020 and reviewed by the Orthopedic panel.
What device class is SAI?
Class II, regulation 21 CFR 888.3020. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAI?
Across 2 cleared submissions the average was 331 days from receipt to decision (median 331).
Which companies have the most SAI clearances?
Restor3D, Inc. (1); 4Web Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAI
- Run a recall and safety report across every SAI manufacturer
- Watch product code SAI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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