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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. 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.

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