Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3020](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3020) → SAI — Ankle Fusion Cage

# SAI · Ankle Fusion Cage

_Orthopedic · 21 CFR 888.3020 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/SAI

## Overview

- **Product Code:** SAI
- **Device Name:** Ankle Fusion Cage
- **Regulation:** [21 CFR 888.3020](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3020)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K242356](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/SAI/K242356.md) | TIDAL Fusion Cage System | Restor3D, Inc. | Mar 24, 2025 | SESE |
| [K230088](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/SAI/K230088.md) | Ankle Truss System (ATS) | 4Web Medical, Inc. | Mar 21, 2024 | SESE |

## Top Applicants

- 4Web Medical, Inc. — 1 clearance
- Restor3D, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/SAI](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/SAI)

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