(85 days)
Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant and is intended for cemented application only.
The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings.
This is a 510(k) premarket notification for a medical device (Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis), not a study evaluating software or an AI device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI device performance metrics (like sensitivity, specificity, or reader improvement) is not applicable here.
The document discusses the substantial equivalence of the "Maxim Removable Molded Poly Tibia" prosthesis to other commercially available tibial components based on its function and overall design. The FDA's letter states that they have "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976."
Therefore, I cannot provide the requested information as it pertains to a different type of device assessment than what is presented in the provided text.
§ 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.