Device Dossier

LPS Porous Bowed Stem - Knee stem

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

Intended purpose

The LPS Porous 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 Porous Bowed Stem is made for CoCr with a porous coating and is intended for cementless fixation. The LPS Porous Stem is a universal stem component of the LPS System and connects to either to the proximal femoral component or distal femoral component.

TGA Public Summary