Device Dossier
NOVAE E TH Non Cemented Dual Mobility Acetabular Cups - Acetabular shell
Device Dossier for NOVAE E TH Non Cemented Dual Mobility Acetabular Cups - Acetabular shell (Acetabular shell, Class III, sponsor Compliance Management…
- GMDN category: Acetabular shell
Intended purpose
The shell of an acetabular prosthesis used in hip arthroplasty. The device is manufactured from Stainless Steel and the external surface is porous coated. A separate mobile internal liner is used as the articulating surface. The NOVAE acetabular cups are especially indicated for patients demonstrating a high risk of displacement and for patients over 75 years old. Indicated for osteoarthritis of the hip, cervical fractures, recurring displacements, osteonecrosis, dysplasia, patients at risk of instability (neurology, tumour, revision, desarthrodesis, cognitive disorders, etc.), supplementary anchoring with 2 pins (ischium/pubis attachment) + attachment screws. Surgical revision, Type 1 to Type 2C bone loss according to the Paprowski classification.
Functional description
NOVAE E 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. NOVAE E has piercings in the bearing arm which are designed to receive cortical screws 5mm in diameter. 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.