SMAIO has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its patient-specific K-rod union rods which, combined with the firm’s Kheiron posterior spinal fixation system, 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 rods to North American surgeons for the first time.
Philippe Roussouly, CEO of SMAIO, said: “In 2012, SMAIO was the first company in the world to unveil spinal realignment surgical planning software capable of simulating the compensations of the patient’s imbalances at pelvic and thoracic level. Today, on the strength of the experience acquired through thousands of cases of surgical planning undertaken for hundreds of surgeons with the majority of implantable devices that exist on the market, SMAIO is able to provide its own holistic solution combining planning, execution and evaluation of results via its i-kontrol platform.
“Thanks to the 510(k) clearance obtained for K-rod, our solution can now be offered in its entirety in North American medical centres. Indeed, 510(k) clearance for this patient-specific rod technology, following that received for the Balance Analyzer 3D surgery planning software last month and the Kheiron spinal fixation system in October 2020, will enable us to accelerate the distribution of the i-kontrol holistic solution in the United States, in line with our global strategy, which aims to make spine surgery more effective, safer and more predictable.”