Device Dossier

Lubinus SPII Hip Prosthesis Stem - Uncoated hip femur prosthesis, modular

Device Dossier for Lubinus SPII Hip Prosthesis Stem - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor…

Intended purpose

Prosthesis stem component of the Lubinus SP II Anatomically Adapted Hip Prosthesis System indicated for use in treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures • Primary and secondary coxarthrosis • Osteoarthritis • Necrosis of the femoral head • Femoral neck fractures • Revision after implant loosening [long stem prosthesis]

Functional description

The prosthesis stem is an anatomical shaped hip prosthesis stem for cemented fixation in the human body. • Minimal bone resection • Uniform cement mantle around the whole stem • Anatomically shaped stem resists rotational forces Modular system allows adjustment to suit anatomical conditions

TGA Public Summary