ARTG 476348Journey II Insert XLPE Deep Dished - Prosthesis, knee, internal, insert component
ARTG ID: 476348 · Smith & Nephew Pty Ltd · Smith & Nephew Inc · Class III · Started January 22, 2025
Good Name: Smith & Nephew Pty Ltd - Journey II Insert XLPE Deep Dished - Prosthesis, knee, internal, insert component
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 476348
- Start Date
- January 22, 2025
- Effective Date
- January 22, 2025
- Country
- United States of America
- Address
- 1450 Brooks Rd, Memphis, Tennessee, 38116
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.
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.
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