Trident II Clusterhole HA Acetabular Shell - Acetabular shell - ARTG 321441
Access comprehensive regulatory information for Trident II Clusterhole HA Acetabular Shell - Acetabular shell in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 321441 and sponsored by Stryker Australia Pty Ltd, manufactured by Howmedica Osteonics Corporation in United States of America. The device registration started on August 08, 2019.
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Intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. Indications for Use - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM Liners - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. - Dislocation risks When used with Constrained Liner - The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.