Device Dossier

CoreHip Cemented Stem - Uncoated hip femur prosthesis, modular

Device Dossier for CoreHip Cemented Stem - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor B Braun).…

Intended purpose

The implant is used: • as a component of a human hip endoprosthesis: Hip endoprosthesis stem • in combination with Aesculap hip endoprosthesis components • in combination with implant components explicitly approved by Aesculap • for implantation without bone cement with PLASMAPORE® coated stems • for implantation with bone cement, for uncoated stems and AS coated stems

Functional description

The CoreHip Cemented Stem is a femoral stem manufactured from CoCr alloy that is intended to be used in conjunction with a femoral head in a hip joint replacement procedure. It is also available with the Advanced Surface (AS) coating to address metal hypersensitivity. It is intended for cemented use only. It is compatible with other Aesculap hip prosthetic components.

TGA Public Summary