LimaCorporate and TechMah Medical Secure First FDA 510(k) Clearance for Smart SPACE Shoulder 3D Planning and Positioning System

Udine, Italy, Dec. 10, 2019 /PRNewswire/ -- LimaCorporate is pleased to announce that the Smart SPACE Shoulder 3D Planner and 3D Positioner have received their first FDA (U.S. Food and Drug Administration) 510(k) clearance. Smart SPACE is an innovative digital platform developed collaboratively by TechMah Medical and LimaCorporate; the two companies entered into a milestone-based acquisition agreement last year. In 2014, TechMah Medical was founded by the University of Tennessee (University of Tennessee) Professor of Biomedical Engineering Muhammad Mahfouz (Mohamed Mahfouz) founded by Dr.

First, the Smart SPACE platform provides physicians with an intuitive, physician-driven software solution that enables 3D preoperative planning and delivers a 3D locator to support intraoperative positioning. Subsequently, the platform will integrate an intraoperative surgical guidance system, designed to streamline shoulder arthroplasty procedures and facilitate precise, personalized patient care.

This approval marks a key milestone for Smart SPACE, enabling Lima Corporate to integrate its superior hardware with groundbreaking 3D printing technology, now complemented by its proprietary, patented software. The full launch of Smart SPACE will be applied in shoulder, hip, and knee joint replacement surgeries.

Luigi Ferrari, CEO of LimaCorporate (Luigi Ferrari) commented, “By taking this transformative first step now, we are on the path to making a significant contribution to changing the way orthopedic surgeries are performed today. We will leverage digital technologies, combined with hardware, to transform current orthopedic surgical practices and empower physicians with access to diverse resources.”