Silo Tfx Mis Sacroiliac Joint Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221047 FDA 510(k)
- FDA Product Code
- OUR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Silo Tfx Mis Sacroiliac Joint Fixation System is a medical device intended for sacroiliac joint fusion. It features a titanium alloy transfixing bridge with a hollow, conical-shaped barrel and four lateral openings designed to accommodate bone graft material for fusion.
The system includes two holes used to transfix screws through the sacrum and the ilium to ensure stability. This device has received FDA 510k clearance.
Frequently asked questions
What is the primary purpose of the Silo Tfx Mis Sacroiliac Joint Fixation System?
This device is intended for sacroiliac joint fusion. It utilizes a titanium alloy transfixing bridge with a hollow, conical-shaped barrel to facilitate the fusion process.
How does the device support bone graft integration?
The system features four lateral openings within the conical barrel. These openings are specifically designed to accommodate bone graft material, which supports the intended fusion of the joint.
How is the device secured in the patient?
The system includes two dedicated holes that allow for the placement of transfixing screws through both the sacrum and the ilium. This configuration is designed to ensure stability across the sacroiliac joint.
What is the regulatory status of this system?
The Silo Tfx Mis Sacroiliac Joint Fixation System has received FDA 510k clearance, as indicated by the K221047 submission filed by Aurora Spine, Inc.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SiLO TFX™ - Transfixing The SI Joint - Aurora Spine, SiLO™ Allograft - Sacroiliac Joint Fusion — Aurora - Aurora Spine, PDF SURGICAL TECHNIQUE GUIDE SiLO TFX
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221047 | Class II | Active |
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Manufacturer
- Manufacturer
- Aurora Spine, Inc.
Sources (1)
- FDA 510(k) K221047 24 fields · synced Sep 22, 2026