Medacta Receives FDA Clearance for Anatomic and Reverse Shoulders

By Julie A. Vetalice

Medacta received FDA 510(k) clearance to market Anatomic Shoulder and Reverse Shoulder components of its modular Medacta Shoulder system. U.S. launch will occur in 1Q18.

The news accompanies successful completion of the first U.S. procedure using the Medacta shoulder.

The system debuted in Europe in 1Q17. It comprises a range of sizes, adjustable offset, a variety of configurations and CT-based MyShoulder 3D pre-op planning for patient-specific humeral and glenoid guides. The Medacta Shoulder can convert from total to reverse arthroplasty without the need to revise all components.

The Medacta Shoulder is part of a multi-center, postmarketing, prospective, open clinical study that will collect clinical and radiological outcomes for the next ten years.

Source: Medacta International

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory