LimaCorporate Gains Regulatory Approvals for Smart SPACE Digital Platform

By Julie A. Vetalice

LimaCorporate Gains Regulatory Approvals for Smart SPACE Digital Platform

LimaCorporate announced a variety of regulatory approvals for the Smart SPACE digital platform, used in shoulder replacement applications.

Lima gained access to the technology through its acquisition of TechMah Medical in 2018.

TechMah gained FDA 510(k) clearance in December 2020 to market the proprietary Smart SPACE Humeral 3D Positioner for total shoulder arthroplasty (TSA), followed in February 2021 by clearance for its Smart SPACE Cubit Guidance for TSA. Further, in January 2021, Lima received approval under the CE Mark for the Mac OS version of the Smart SPACE 3D Virtual Planner.

Smart SPACE Humeral 3D Positioner and Shoulder Cubit Guidance applications are designed to enable the surgeon and enhance the predictability of surgical outcomes.

The Smart SPACE Shoulder Planner is currently in controlled release within the U.S. and Europe. LimaCorporate plans full release of the Shoulder Planner later in 1Q21 and initial surgeries with the Humeral 3D Positioner and Shoulder Cubit Guidance in 2Q21.

Luigi Ferrari, LimaCorporate CEO, said, "Following with our tradition of innovation, we are planning a significant number of new product releases in 2021. We are thrilled that many of these will involve Smart SPACE, our contribution to transform orthopedics."

Product Labels: Shoulder Replacement, Surgical Planning

Tags: 510(k) Clearance, CE Mark, Regulatory