Device Dossier

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

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

Intended purpose

The Vivacit-E Vitamin E Highly XLPE Neutral 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 Neutral Liners are a series of acetabular liners manufactured from vitamin E (α-tocopherol) blended, highly crosslinked UHMWPE. Each liner is identified with a two letter size code (e.g. JJ) that corresponds to the mating acetabular shell. Liners are secured to the respective shell by engaging a protruding polyethylene rim with an integrated locking groove in the shell. Available in standard zero degree elevation. Intended for both cemented and cementless use.

TGA Public Summary