Australia TGA ARTG record

OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis

Australia TGA ARTG Registered Device · Zimmer Biomet Pty Ltd · Biomet Orthopedics · Class III · Started June 27, 2024

Good Name: Zimmer Biomet Pty Ltd - OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis

Device classification

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

Registration information

Start Date: June 27, 2024
Effective Date: June 27, 2024

Sponsor

Name: Zimmer Biomet Pty Ltd

Manufacturer

Name: Biomet Orthopedics
Country: United States of America
Address: 56 East Bell Drive PO Box 587, Warsaw, IN, 46581

Intended purpose

The OSS AVL non-modular tibial baseplate long is a component of the OSS Orthopaedic Salvage System intended for limb salvage procedures, resurfacing and revision applications. OSS System Indications: - Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. - Correction of varus, valgus, or posttraumatic deformity. - Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. - Ligament deficiencies. - Tumour resections. - Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. - Revision of previously failed total joint arthroplasty. - Trauma.

About this record

Access comprehensive regulatory information for OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet Orthopedics in United States of America. The device registration started on June 27, 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.