Redapt Fully Porous Acetabular Shells - Acetabular shell - ARTG 463125
Access comprehensive regulatory information for Redapt Fully Porous Acetabular Shells - Acetabular shell in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 463125 and sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc in United States of America. The device registration started on September 30, 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.
The REDAPT Porous Acetabular Shells are designed for uncemented fixation. Bone cement may be used to join augments within the REDAPT Porous Acetabular Shells. The REDAPT Porous Acetabular Shell for use with the POLARCUP Dual Mobility System is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement. 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 In Australia, the REDAPT Acetabular System is indicated for revision surgery only.