www.fdanews.com/articles/188305-amdts-fixsix-system-cleared-by-fda
AMDT’s FixSix System Cleared by FDA
September 6, 2018
The FDA granted 510(k) clearance to AMDT’s FixSix software and instrumentation, used to analyze and correct limb deformities.
Intended for use with the Smith and & Nephew Taylor spatial frame, the system reduces the time and effort needed for inputting measurements.
After inputting the measurement data, the system generates a prescription defining incremental adjustments to be made to the spatial frame’s strut that will correct the deformity.