Device Dossier
LPS Porous Straight Stem - Knee stem
Device Dossier for LPS Porous Straight Stem - Knee stem (Knee stem, Class III, sponsor DePuy Synthes). ARTG record, intended purpose, GMDN category —…
- GMDN category: Knee stem
Intended purpose
The LPS Porous Straight Stem is the universal stem component of the Limb Preservation System (LPS) which is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, 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 Straight Stem is made for CoCr with a porous coating and is intended for cementless fixation. The LPS Porous Straight Stem is a universal stem component of the LPS System and connects either to the proximal femoral component, distal femoral component, proximal tibial component or intercalary/segmental component.