Device Dossier

Continuum®, Trilogy® IT, Allofit® IT Acetabular Systems Vivacit-E™ Vitamin E Highly Crosslinked Polyethylene Elevated Rim Liner - Non-constrained polyethylene acetabular liner

Device Dossier for Continuum®, Trilogy® IT, Allofit® IT Acetabular Systems Vivacit-E™ Vitamin E Highly Crosslinked Polyethylene Elevated Rim Liner -…

Intended purpose

The Vivacit-E Vitamin E Highly XLPE Elevated Rim Liners are a component of the Continuum®, Trilogy® IT, and Allofit® IT Alloclassic®, and 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

Vivacit-E HXPE Elevated Rim Liners are manufactured from vitamin E (α-tocopherol) blended, HXPE. Each liner is identified with 2 letter code corresponding to the mating acetabular shell. Liners are secured to the respective shell by engaging a protruding PE rim with an integrated locking groove in the shell. Features 15° elevated rim. Approximately 120° of the liner face is elevated to provide additional femoral head coverage, resulting in slight ROM decrease. For cemented and uncemented use.

TGA Public Summary