Zimmer Biomet Gains FDA 510(k) Clearance for PERSONA Revision Knee

By Julie A. Vetalice

Zimmer Biomet (ZBH) received FDA 510(k) clearance to market the PERSONA® revision knee system, featuring patient-specific components.

PERSONA revision utilizes Trabecular Metal technology, a porous biomaterial made from Tantalum with properties similar to cancellous bone. It's been used in >2MM orthopaedic devices and is backed by >20 years of clinical results.

PERSONA also employs Vivacit-E®, a highly cross-linked polyethylene material designed with actively stabilized Vitamin E to protect against oxidation and maintain wear resistance and strength throughout an implant’s life.

In this week’s 3Q18 earnings call, ZBH leadership cited the PERSONA knee portfolio (including partial, tibia and revision) as an important growth opportunity for the company.

Sources: Zimmer Biomet; ORTHOWORLD, Inc.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory