(66 days)
The DePuy 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 joint disease (IJD), e.g., theumatoid 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 is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The distal femoral component, the S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The DePuy LPS Proximal Tibial Component is a modular component that is designed to replace the proximal portion of the tibia. Unlike primary knee systems, the LPS System is used when the amount of bone resection and replacement is extreme (e.g. in oncology cases or endstage revision).
The distal end of the LPS Proximal Tibial Component has a female Morse-type taper that is designed to accept either a DePuy LPS Segment Component or a tibial stem. The proximal/superior surface is designed with a central stem hole to allow it to accept the stem of the LPS tibial plateau/hinge assembly. The top surface has a highly polished mirror pr nish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly. The anterior surface has a Porocoat beaded Co-Cr-Mo porous coating.
This document is a 510(k) summary for a medical device called the "DePuy LPS Proximal Tibial Component." It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it involve an AI/algorithm-based device.
Therefore, I cannot provide the requested information in the format specified because the input text does not contain any of the details required for such a response, particularly regarding acceptance criteria, performance metrics, ground truth, expert involvement, or AI/algorithm performance studies.
Based on the provided text, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment) is available as this is a traditional medical device submission, not an AI-powered one.
§ 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.