FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System
The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement.
The shoulder includes the glenohumeral joint, which is the ball-and-socket joint where the head of the humerus (i.e., the ball) joins the glenoid (i.e., the shoulder socket in the scapula). However, when the associated tendons are damaged, reverse shoulder replacement or arthroplasty may be used to repair the joint. In reverse shoulder replacement, the ball and socket of the glenohumeral joint are replaced in opposite positions. As such, the ball is placed on the socket side of the joint and the socket is placed on the ball (i.e., arm) side where it is typically supported by a stem that is implanted in the humerus. LimaCorporate reports that its new PRIMA TT Glenoid system includes a 3D-printed convertible short stem and a fully 3D-printed glenoid replacement for Reverse Shoulder Arthroplasty.
According to a press release, LimaCorporate’s PRIMA TT Glenoid system uses trabecular titanium (TT), which is lightweight biomaterial containing titanium and having a regular three-dimensional hexagonal cell structure that imitates trabecular bone morphology, which is designed to encourage strong primary fixation and secondary bone ingrowth. In response to the FDA’s approval of the PRIMA TT Glenoid system, LimaCorporate’s CEO Massimo Calafiore stated “Today’s FDA approval for PRIMA TT Glenoid represents an exciting opportunity to accelerate our market growth in key regions. The new PRIMA shoulder platform will support our surgeons to bring the emotion of motion to even more patients!”
LimaCorporate states it is planning to launch the PRIMA TT Glenoid shoulder replacement system in 2023.