ARTG 422160Link Endo-Model EVO Condylar hinge knee tibial component - Rotating hinged total knee prosthesis
ARTG ID: 422160 · Link Orthopaedics Australia Pty Ltd · Waldemar Link GmbH & Co KG · Class III · Started September 21, 2023
Good Name: Link Orthopaedics Australia Pty Ltd - Link Endo-Model EVO Condylar hinge knee tibial component - Rotating hinged total knee prosthesis
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 422160
- Start Date
- September 21, 2023
- Effective Date
- September 21, 2023
- Country
- Germany
- Address
- Barkhausenweg 10, Hamburg, 22339
The LINK Endo-Model EVO Knee System is a non-active, surgically-invasive, implantable device which is intended for long-term replacement of a diseased and/ or defective knee joint in the human body. It can be used with full-grown, anesthetized patients of any ethnic origin and sex. The LINK Endo-Model EVO Knee System is implanted with or without cement related to the selected implant version. The tibial component is generally indicated for use in mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. These include primary and secondary osteoarthritis; rheumatoid arthritis; revision after primary or revision total knee replacement, bone necrosis, varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers; oncological and revision surgery in lower limb (in conjunction with the Endo-Model W/ Endo-Model EVO-W and the Megasystem-C).
Access comprehensive regulatory information for Link Endo-Model EVO Condylar hinge knee tibial component - Rotating hinged total knee prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 422160 and sponsored by Link Orthopaedics Australia Pty Ltd, manufactured by Waldemar Link GmbH & Co KG in Germany. The device registration started on September 21, 2023.
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.