Device Dossier

NOVAE STICK Cemented Dual Mobility Cup - Acetabular shell

Device Dossier for NOVAE STICK Cemented Dual Mobility Cup - Acetabular shell (Acetabular shell, Class III, sponsor Compliance Management Solutions). ARTG…

Intended purpose

The NOVAE acetabular cups are especially indicated for patients demonstrating a high risk of displacement and for patients over 75 years of age. The indications for use of the NOVAE STICK include the following: o Osteoarthritis of the hip, cervical fractures, recurring displacements, patients at risk of instability (neurology, tumour, revision, desarthrodesis, cognitive disorders), or where primary stability may be compromised. o This particular cup is particularly indicated in cases where the bones are osteoporotic. o Rehabilitation after large-scale acetabular destruction, by cementing the acetabular cup into a fixed reinforcement.

Functional description

The NOVAE STICK Cemented Dual Mobility Cup is manufactured from Stainless steel and has a sanded exterior for cemented use. The cup can be assembled only with polyethylene liners of the CI series. It is packaged with a disposable positioning ring in order to avoid micromovement of the cup during cement hardening.

TGA Public Summary