Australia TGA ARTG record

Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable

Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes · Depuy Mitek (a Johnson & Johnson Company) · Class III · Started July 29, 2016

Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable

Device classification

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

Registration information

Start Date: July 29, 2016
Effective Date: July 29, 2016

Sponsor

Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Name: Depuy Mitek (a Johnson & Johnson Company)
Country: United States of America
Address: 325 Paramount Drive, Raynham, MA, 02767

Intended purpose

HEALIX ADVANCE BR Anchors with Permacord are indicated for use in soft tissue to bone fixation as follows: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar and Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair.

About this record

Access comprehensive regulatory information for Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy Mitek (a Johnson & Johnson Company) in United States of America. The device registration started on July 29, 2016.

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.