(31 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Non-coated (Interlok®) devices are indicated for cemented application only.
Biomet® Microplasty Tibial Trays are designed to hold the tibial knee bearings in a microplasty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem to allow for easier insertion through a minimally invasive incision.
The provided 510(k) summary for the Biomet® Microplasty Tibial Tray states that clinical testing was not conducted in support of substantial equivalence. Therefore, there is no information available in this document regarding acceptance criteria or a study proving the device meets them through clinical performance.
The submission relies on non-clinical testing and substantial equivalence to a predicate device (Interlok® Primary Tibial Trays - K915132) based on technological similarity.
The document states: "All parameters of the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses" that applied to the tibial components in this 510(k) were met." This indicates that the device met specific non-clinical performance criteria outlined in the guidance document for this type of device. However, the specific quantitative acceptance criteria and the results of those non-clinical tests are not detailed in this summary.
Given the information provided, I cannot populate the requested table or answer the specific questions about clinical study design, sample size, ground truth, or MRMC studies, as none were performed or reported.
§ 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.