Device Dossier
Continuum® Acetabular System Trabecular Metal™ Shell, with Uni-hole Porous - Acetabular shell
Device Dossier for Continuum® Acetabular System Trabecular Metal™ Shell, with Uni-hole Porous - Acetabular shell (Acetabular shell, Class III, sponsor…
- GMDN category: Acetabular shell
Intended purpose
The Continuum TM Shell is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusion acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Functional description
The TM Shell is a component of the modular Continuum Acetabular System. The shells are made from Tivanium® Ti-6Al-4V Alloy with Trabecular Metal™ material (Tantalum) that is metallurgically bonded to the exterior of the shell. The uni-hole shell is designed for applications where no screws are desired, with a single polar dome hole to aid in shell placement and to provide visual confirmation that the shell is fully seated into the acetabulum. Intended for use either with or without bone cement.