Medacta Gains FDA Clearance for Short Humeral Diaphysis

By Julie A. Vetalice

Medacta received FDA 510(k) clearance to market a Short Humeral Diaphysis used with the Medacta Shoulder System.

The device, an alternative to the Standard version, replaces the humeral side of the gleno-humeral joint in primary and reverse shoulder replacement. It is manufactured from titanium alloy and available in 11 sizes.

Medacta offers a full line of hip, knee and shoulder joint reconstruction devices. The modular shoulder with which this new diaphysis is compatible was launched in 1Q18.

Sources: Medacta International; ORTHOWORLD Inc.

 

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory