Device Dossier
Trabecular Metal™ Modular Acetabular Shells - Acetabulum prosthesis
Device Dossier for Trabecular Metal™ Modular Acetabular Shells - Acetabulum prosthesis (Acetabulum prosthesis, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Acetabulum prosthesis
Intended purpose
The Trabecular Metal Modular Acetabular System with a Trilogy Neutral, Elevated, Offset or Oblique Liner is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. • The Trabecular Metal Modular Acetabular System with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthorplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. • This device is intended for either cemented or noncemented use.
Functional description
Shell component of a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The shells are available with screw holes, cluster screw holes or without screw holes. The Inner diameter of acetabular shell, locking ring, and screws is made from Tivanium® Ti-6Al-4V Alloy while the External surface of acetabular shell is made fro Trabecular Metal Material (Tantalum.