Device Dossier
NOVAE COPTOS TH Non Cemented Dual Mobility Acetabular Cup - Acetabular shell
Device Dossier for NOVAE COPTOS TH Non Cemented Dual Mobility Acetabular Cup - Acetabular shell (Acetabular shell, Class III, sponsor Compliance…
- GMDN category: Acetabular shell
Intended purpose
NOVAE COPTOS 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 COPTOS TH Cup may be used for the following conditions, as appropriate: 1. Osteoarthritis of the hip, cervical fractures, recurring displacements, patients at risk of instability (neurology, tumour, revision, desarthrodesis... cognitive disorders), supplementary anchoring with 2 pins (ischium/pubis attachment) + attachment screws 2. Surgical revision, Type 2A to Type 2C and 3B 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
This device is made of Stainless Steel with a titanium spray and a layer of hydroxyapatite. This dual coating strengthens primary fixation stability and increases longevity. The cup has 2 flanges and a hook. The piercings in the bearing arm 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. For use with a mobile polyethylene insert which articulates around the prosthetic head.