Device Dossier
Trilogy® IT Acetabular System Shell, Porous, with Calcicoat® Ceramic Coating - Acetabular shell
Device Dossier for Trilogy® IT Acetabular System Shell, Porous, with Calcicoat® Ceramic Coating - Acetabular shell (Acetabular shell, Class III, sponsor…
- GMDN category: Acetabular shell
Intended purpose
The Trilogy IT Acetabular 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, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Functional description
Trilogy IT Shell is a part of the Trilogy® IT Acetabular System. Available with multi or cluster screw holes to provide additional fixation and security in cases where acetabular bone stock is deficient. Made from Tivanium® Ti-6Al-4V Alloy with commercially pure Titanium fiber metal metallurgically bonded to shell exterior. Calcicoat is plasma sprayed onto porous fiber metal surfaces for implant stability by allowing biological fixation of bone to the implant. Used with or without bone cement.