FDA Product Code SAI: Ankle Fusion Cage
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.
Leading manufacturers include 4Web Medical, Inc. and Restor3D, Inc..
FDA 510(k) Cleared Ankle Fusion Cage Devices (Product Code SAI)
About Product Code SAI - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SAI since 2024, with 2 receiving FDA clearance (average review time: 331 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under SAI have taken an average of 228 days to reach a decision - down from 434 days historically, suggesting improved FDA processing for this classification.
SAI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →