Redapt Cemented XLPE Liners - Non-constrained polyethylene acetabular liner - ARTG 463427
Access comprehensive regulatory information for Redapt Cemented XLPE Liners - Non-constrained polyethylene acetabular liner in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 463427 and sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc in United States of America. The device registration started on October 02, 2024.
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.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip REDAPT Cemented Liners are to be implanted with bone cement. The REDAPT Fully Porous Shell and REDAPT Cemented Liner combination is for use in complex primary and revision surgeries only. In Australia, the REDAPT Acetabular System is indicated for revision surgery only.