(28 days)
The Trabecular Metal Femoral Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Femoral Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
The Trabecular Metal Femoral Cone Augments are to be used in conjunction with Zimmer Inc.'s LCCK and Rotating Hinge Knee femoral components. The subject devices are used to fill femoral cavitary defects encountered when implanting either of these two systems. The design of the augment interface inversely corresponds to the design of an LCCK or Rotating Hinge Knee femoral component. The augment has a rectangular, tapered shape. The opposing sides of the rectangle are longer than the center allowing the sides of the augment to fit into the condyles of the femoral component. The center of the augment is hollow to allow passage of the stem through the center of the cone and into the femoral canal. The augments are fixed to the femoral component with bone cement. The Trabecular Metal Femoral Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.
The provided text is a 510(k) summary for the Zimmer Trabecular Metal Femoral Cone Augments. It explicitly states that "Testing of the subject devices were not performed."
Therefore, it is impossible to describe acceptance criteria and a study proving the device meets them from the given document. The submission relies on a comparison to predicate devices and previous testing of the Trabecular Metal material itself to establish substantial equivalence, rather than new performance testing of the augments.
As a result, I cannot provide the requested information, including tables of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, because these data were not included in the provided 510(k) submission.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.