(90 days)
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
The Repicci II Unicondylar Knee consists of femoral and tibial components. The femoral component is anatomic in design.to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right configurations. A central keel and post on the back of the device assist in cement fixation. The device is manufactured from cobalt alloy. Two styles of tibial components are available with this system, an all polyethylene component and a modular metal backed component. The all polyethylene component is universal in geometry. A waffle pattern on the under surface assists in initial fixation. A modular tibial component consists of a metal tray and a polyethylene bearing which is snap fit into the tray by the surgeon.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification approval letter for the Repicci II Unicondylar Knee, which primarily addresses the device's substantial equivalence to a predicate device and outlines limitations and regulatory requirements. It does not include details on performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the specific questions asked.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.