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Medartis announced that it received FDA 510(k) clearance to market its CalcShift system for displacement calcaneal osteotomies. The system is one of several new lower extremity products scheduled for U.S. launch in 2023.
The CalcShift system is one of several new lower extremity products scheduled for launch in the U.S. in 2023. Photo courtesy of Medartis.
Indicated for osteotomies, non-unions, malunions, revisions, fusions and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy, the new CalcShift system from Medartis features a streamlined instrumentation platform allowing surgeons to perform minimally invasive or traditional open medial or lateral displacement osteotomies with consistently reproducible results.
The system, which features a low-profile pocket plate with locking and non-locking screws as well headless cannulated screw options, is the latest offering that Medartis has developed in close partnership with its U.S. surgeon design team. Surgeons have the option of performing a calcaneal displacement osteotomy minimally invasive or using traditional open technique without additional assistance in the O.R.
The CalcShift Displacement Calcaneal Osteotomy System is manufactured by Nextremity Solutions, which Medartis recently acquired.
“We’re excited about the recent 510(k) clearance of our new CalcShift system,” Ryan Schlotterback, Chief Technology Officer, Medartis, said. “This system is another great example of our surgeon partners helping us create an instrumented system to assist them in making what can be perceived as a challenging procedure easy and repeatable while giving them confidence in achieving the desired correction. As we’ve done in the past, the team has created a well instrumented system that provides our surgeons multiple fixation options.”
