(86 days)
The DePuv LPS 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 ioint 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. .
It is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The porous-coated metaphyseal and diaphyseal sleeves are intended for either cemented or cementless applications.
The technological characteristics of the DePuy LPS Universal Technological Hinge Insert Assembly are similar to the predicate devices Characteristics: including design, performance and material type.
This is a 510(k) summary for a medical device (DePuy LPS Universal Hinge Insert Assembly) and does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document discusses:
- The device's intended use and classification.
- Its substantial equivalence to predicate devices based on design, performance, and material type, as demonstrated by pre-clinical data (not clinical study data).
- The FDA's decision to clear the device for market.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment. The provided text is a regulatory filing, not a scientific study report.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.