(77 days)
This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell turnors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur: and. severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacentent(s) of the proximal and/or distal femur.
The Modular Options for Severe bone loss and Trauma (MOST) System will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary, Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this system allows for the resection of varying amounts of the femur (and the proximal tibia and patella, if necessary) before implantation. A total replacement is possible in those cases where no part of the femur can be salvaged. The components of the MOST System include: the proximal femoral replacement that is available in two designs to address the presence or absence of the greater rochanter, with sunure holes for soft tissue attachment; the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, allowing 15 degrees of internal and external rountion; intramedullary (I/M) stems with Cancellous Structured Titanium (CSTi) and femoral segments which will be used in conjunction with the proximal and distal replacements, and, an all-poly patella.
This is a description of a medical device (a prosthetic system) and not a diagnostic AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in this context.
The document discusses the product description, diagnostic indications, and substantial equivalence to other existing prosthetic systems based on design and intended use, rather than performance metrics related to diagnostic accuracy or AI model evaluation.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.