Australia TGA ARTG record

Custom-made orthopaedic surgical guide, non-sterile

Australia TGA ARTG Registered Device · MicroPort Orthopedics Pty Ltd · MicroPort Orthopedics Inc · Class IIa · Started December 15, 2023

Good Name: MicroPort Orthopedics Pty Ltd - Custom-made orthopaedic surgical guide, non-sterile

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 15, 2023
Effective Date: December 15, 2023

Sponsor

Name: MicroPort Orthopedics Pty Ltd

Manufacturer

Name: MicroPort Orthopedics Inc
Country: United States of America
Address: 5677 Airline Road, Arlington, TN, 38002

Intended purpose

Patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort’s EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

About this record

Access comprehensive regulatory information for Custom-made orthopaedic surgical guide, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by MicroPort Orthopedics Pty Ltd, manufactured by MicroPort Orthopedics Inc in United States of America. The device registration started on December 15, 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.