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…
- GMDN category: Uncoated hip femur prosthesis, modular
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