LimaCorporate, TechMah announce FDA approvals for Smart Space technology
LimaCorporate and its recently acquired TechMah Medical LLC have received FDA clearances for Smart Space orthopedic technology, according to a press release.
TechMah Medical received 510(k) clearance for its Smart Space Humeral 3D Positioner on Dec. 28, 2020 and for its Smart Space Shoulder Cubit Guidance on Feb. 3, 2021. An Apple Macintosh OS version of the Smart Space 3D Virtual Planner by LimaCorporate received a CE mark on Jan. 19, 2021.
Smart Space is LimaCorporate’s digital platform and is designed to enhance the predictability of surgical outcomes. “Surgeons using the system receive real-time feedback regarding instrument and implant positioning, all while maintaining their desired OR and patient set up,” according to the company.
“Following with our tradition of innovation, we are planning a significant number of new product releases for 2021. We are thrilled that many of our new product releases in 2021 involve Smart Space, our contribution to transform orthopedics in 2021,” Luigi Ferrari, CEO of LimaCorporate, said in the release.
The Smart Space Shoulder Planner currently has a controlled release within the United States and Europe. Commercial release of the shoulder planner is expected in the first quarter of 2021, with surgeries using the Humeral 3D Positioner and Shoulder Cubit Guidance expected in the second quarter of the year.
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