Medacta Receives FDA Clearance for the Lateralized Glenosphere

By Julie A. Vetalice

Medacta Receives FDA Clearance for the Lateralized Glenosphere

Medacta was granted FDA 510(k) clearance to market its Lateralized Glenosphere. This implant, which received CE Mark approval in 2019, grows the company's offering for shoulder arthroplasty, including options for reverse shoulder replacement.

The implant features a more lateralized center of rotation vs. the company's standard glenosphere in the Medacta Shoulder System. Potential benefits include an improved range of motion and a reduced risk of scapular notching.

Earlier in 2020, the Medacta Shoulder System expanded with the introduction of the Long Humeral Diaphysis, indicated for shoulder replacement in complex cases or when extended distal fixation is needed.

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory