SMAIO (S.M.A.I.O S.A.) announced that it has received FDA 510(k) clearance for “K-rod”, its patient-specific rod. K-rod union rods are patient specific, respecting the patient's anatomy, due to the accurate 3D modeling undertaken with SMAIO's KEOPS Balance Analyzer 3D software. Combined with the Kheiron posterior spinal fixation system, they enable the strict alignment of the spine on the rod.

The K-rod range has been marketed in Europe since June 2019, and obtaining this 510(k) clearance allows SMAIO to offer these innovative rods to North American surgeons for the first time.