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FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System

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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.

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FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System Headshot

Kregg Koch

Kregg A. Koch is an associate in our Los Angeles office. His practice focuses on mechanical and medical devices in the areas of patent prosecution, counseling, licensing, and litigation.

In addition to his educational background in mechanical engineering, Mr. Koch spent several years working as a mechanical design engineer on the Space Shuttle's rocket engine program for The Boeing Company. In particular, he worked as a conceptual design and manufacturing support engineer. While working on this program, Mr. Koch received NASA’s Space Flight Awareness Award for engine safety related contributions.

Mr. Koch joined the firm in 2007.

View all posts published by Kregg Koch
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