SAI

Ankle Fusion Cage

Product code: SAI
Device name: Ankle Fusion Cage
Device class: Class 2
21 CFR: 21 CFR 888.3020
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 2

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-03-24.

Number	Decision date	Applicant	Device name	Summary
K242356	2025-03-24	Restor3D, Inc.	TIDAL Fusion Cage System	FDA
K230088	2024-03-21	4Web Medical, Inc.	Ankle Truss System (ATS)	PDF

1 summaries are archived here for direct download.

Official FDA classification page: SAI

Classification and pathway per current FDA publications. Data from openFDA (CC0).