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Unity Knee CS Tibial insert - Prosthesis, knee, internal, insert component - ARTG 460706

Access comprehensive regulatory information for Unity Knee CS Tibial insert - 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 460706 and sponsored by Corin Australia Pty Ltd, manufactured by Corin Limited in United Kingdom. The device registration started on August 26, 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.

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Class III
ARTG 460706
Class III
Unity Knee CS Tibial insert - Prosthesis, knee, internal, insert component
ARTG ID: 460706
Good Name: Corin Australia Pty Ltd - Unity Knee CS Tibial insert - Prosthesis, knee, internal, insert component
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Intended Purpose

The Unity Kneeโ„ข is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. The Unity Knee CS Tibial insert is designed to securely fix with the locking mechanism on the Unity Kneeโ„ข tibial tray and is compatible with the Unity Kneeโ„ข CR Femoral Component only. The condylar stabilized (CS) fixed tibial insert is intended to be implanted in knee joints, where there is a deficiency on the posterior cruciate ligament (PCL) or where the PCL is absent.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460706
Start Date
August 26, 2024
Effective Date
August 26, 2024
Manufacturer
Country
United Kingdom
Address
The Corinium Centre, Cirencester, Gloucestershire, GL7 1YJ