Device Dossier
LPS Proximal Tibia - Rotating hinged total knee prosthesis
Device Dossier for LPS Proximal Tibia - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor DePuy Synthes).…
- GMDN category: Rotating hinged total knee prosthesis
Intended purpose
The LPS Proximal Tibia is the tibial component of the Limb Preservation System (LPS) which is intended for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged. 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 Proximal Tibia is made from CoCr and is porous coated to allow tissue ingrowth. The LPS Proximal Tibia replaces missing proximal tibial bone and mates with segmental, stem components and a universal tibial insert. Intended for cemented use only.