Device Dossier

LPS Cemented Bowed Stem - Knee stem

Device Dossier for LPS Cemented Bowed Stem - Knee stem (Knee stem, Class III, sponsor DePuy Synthes). ARTG record, intended purpose, GMDN category —…

Intended purpose

The LPS Cemented Bowed Stem is a universal stem component of the LPS System which is intended for use in replacement of the proximal or distal femur, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: • malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; • patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; • revision cases for a failed previous prosthesis requiring extensive resection and replacement; • severe trauma requiring extensive resection and replacement. The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

Functional description

The LPS Cemented Bowed Stem is made from CoCr and is intended for cemented fixation. The LPS Cemented Stem also has a porous collar. The LPS Cemented Bowed Stem is a universal stem component of the LPS System and connects to either the proximal femoral component or distal femoral component.

TGA Public Summary