(90 days)
Intended for 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 Uni Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75. The femoral component is available in 4 sizes (S, M, L, XL) and provided in two configurations (left medial/right lateral and right medial/left lateral).
The Uni Knee System tibial components are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 4 sizes (29-37 mm) and 3 thicknesses (7-9 mm).
This document is a 510(k) summary for the Uni Knee, a medical device for partial knee replacement. It states the device is substantially equivalent to legally marketed predicate devices based on design, materials, and indications for use. However, it does not contain any information about acceptance criteria, device performance testing, or clinical studies (such as MRMC, standalone performance, or training set details) that would be needed to answer your questions.
Therefore, I cannot provide the requested information from this document.
Summary of missing information:
- Acceptance Criteria Table: Not present.
- Sample Size and Data Provenance for Test Set: Not mentioned.
- Number and Qualifications of Experts for Ground Truth: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: No mention of such a study or effect size.
- Standalone Performance Study: No mention of such a study.
- Type of Ground Truth Used: Not mentioned.
- Sample Size for Training Set: Not mentioned.
- Ground Truth Establishment for Training Set: Not mentioned.
§ 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.