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Journey II Insert XLPE Deep Dished - Prosthesis, knee, internal, insert component - ARTG 476348

Access comprehensive regulatory information for Journey II Insert XLPE Deep Dished - Prosthesis, knee, internal, insert component in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 476348 and sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc in United States of America. The device registration started on January 22, 2025.

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
ARTG 476348
Class III
Journey II Insert XLPE Deep Dished - Prosthesis, knee, internal, insert component
ARTG ID: 476348
Good Name: Smith & Nephew Pty Ltd - Journey II Insert XLPE Deep Dished - Prosthesis, knee, internal, insert component
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Intended Purpose

Indications for Total Knee Replacement • Rheumatoid arthritis. • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. • Failed osteotomies, unicompartmental replacement, or total knee replacement. • Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. • Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. • Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
476348
Start Date
January 22, 2025
Effective Date
January 22, 2025
Manufacturer
Country
United States of America
Address
1450 Brooks Rd, Memphis, Tennessee, 38116