LimaCorporate, TechMah Gain FDA Clearance for Smart SPACE Digital Technology

By Julie A. Vetalice

LimaCorporate, TechMah Gain FDA Clearance for Smart SPACE Digital Technology

LimaCorporate received FDA 510(k) clearance to market the Smart SPACE Shoulder 3D Planner & 3D Positioner, a digital platform developed by TechMah Medical, whom Lima acquired in 2018.

Smart SPACE offers intuitive, surgeon-driven software that supports 3D pre-operative planning, as well as tools for intraoperative positioning. In next development steps, the platform will integrate intra-operative surgical guidance systems to simplify shoulder arthroplasty and support precision in personalized patient care. When fully launched, Smart SPACE will have applications in the shoulder, hip and knee replacement.

Smart SPACE Shoulder was submitted to FDA in May 2019, and clearance was granted in November 2019.

The predicate device referenced in the clearance is BLUEPRINT Patient Specific Instrumentation, K162800, from Tornier (now owned by Wright Medical). Smart SPACE Shoulder can be used with a variety of Lima's implant systems, including the SMR Reverse and Anatomic, Hybrid Anatomic and Hybrid Reverse models.

“With this first important step now achieved, we are on our way to making a significant contribution to transforming how orthopedic surgery is approached today with digital technologies combined with hardware, all in the hands of the surgeon,” said Luigi Ferrari, CEO of LimaCorporate.

Product Labels: Shoulder Replacement, Surgical Navigation, Surgical Planning

Tags: ["510(k) Clearance","Regulatory"]