DeviceClearance

Product code SAI— Orthopedic

Ankle Truss System (ATS)

Classification name
Ankle Fusion Cage
Device class
Class 2
Regulation
21 CFR 888.3020
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SAI under 21 CFR 888.3020, via openFDA

Market context for product code SAI

FDA has cleared 2 devices under product code SAI between 2024 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SAI

Recent clearances under product code SAI

Data sourced from openFDA. This site is unofficial and independent of the FDA.