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Persona Partial Knee System, Vivacit-E® Highly Crosslinked Polyethylene Partial Articular Surface - Unicondylar knee insert

Access comprehensive regulatory information for Persona Partial Knee System, Vivacit-E® Highly Crosslinked Polyethylene Partial Articular Surface - Unicondylar knee insert in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet Orthopedics in United States of America. The device registration started on May 22, 2020.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class III
Class III
Persona Partial Knee System, Vivacit-E® Highly Crosslinked Polyethylene Partial Articular Surface - Unicondylar knee insert
Australia TGA ARTG Registered Device
Good Name: Zimmer Biomet Pty Ltd - Persona Partial Knee System, Vivacit-E® Highly Crosslinked Polyethylene Partial Articular Surface - Unicondylar knee insert
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Intended Purpose

Vivacit-E® Partial Articular Surface is a part of the Persona Partial Knee System intended for patients with painful and/or disabling knee joints due to the following indications: Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis; traumatic arthritis; previous tibial condyle or plateau fractures with loss of anatomy or function; varus deformities; and revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged. Also indicated for combined use with the Zimmer Gender Solutions Patello-Femoral Joint.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 22, 2020
Effective Date
May 22, 2020
Manufacturer
Country
United States of America
Address
56 East Bell Drive PO Box 587, Warsaw, IN, 46581