ARTG 474125Insignia - Coated hip femur prosthesis, modular
ARTG ID: 474125 · Stryker Australia Pty Ltd · Howmedica Osteonics Corporation · Class III · Started December 19, 2024
Good Name: Stryker Australia Pty Ltd - Insignia - Coated hip femur prosthesis, modular
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 474125
- Start Date
- December 19, 2024
- Effective Date
- December 19, 2024
- Country
- United States of America
- Address
- 325 Corporate Drive, Mahwah, New Jersey, 07430
The indications for use of the total hip replacement prostheses include: 1. noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; 2. correction of functional deformity. Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks Insignia Hip Stems are intended for cementless use only and are intended for total arthroplasty procedures.
Access comprehensive regulatory information for Insignia - Coated hip femur prosthesis, modular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 474125 and sponsored by Stryker Australia Pty Ltd, manufactured by Howmedica Osteonics Corporation in United States of America. The device registration started on December 19, 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.