Device Dossier

NOVAE SUNFIT TH Non Cemented Dual Mobility Acetabular Cup - Acetabular shell

Device Dossier for NOVAE SUNFIT TH Non Cemented Dual Mobility Acetabular Cup - Acetabular shell (Acetabular shell, Class III, sponsor Compliance…

Intended purpose

NOVAE SUNFIT TH Cup is the shell of an acetabular prosthesis used in hip arthroplasty. The device is manufactured from metal, and the external surface is porous coated. A separate mobile internal liner is used as the articulating surface. The device is supplied sterile, and is intended for single use only. NOVAE SUNFIT TH Cup may be used for the following conditions, as appropriate: 1. Osteoarthritis of the hip, cervical fractures, recurring displacements, osteonecrosis, dysplasia, patients at risk of instability (neurology, tumour, revision, desarthrodesis, cognitive disorders, etc.). 2. Surgical revision if bone reconstruction permits, Type 1 to Type 2C bone loss according to the Paprowski classification. The NOVAE acetabular cups are especially indicated for patients demonstrating a high risk of displacement and for patients over 75 years old.

Functional description

NOVAE SUNFIT TH dual mobility cups are made of Stainless Steel with a titanium spray and a layer of hydroxyapatite. This dual coating strengthens its primary fixation stability and increases longevity. The front of the cup features three 120° areas and a ridged pattern to create a perfect pressfit. Intended for use with a mobile polyethylene insert which articulates around the prosthetic head.

TGA Public Summary