(39 days)
The Competitor Unicondylar All-Poly Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques
The all-poly baseplate components are single use only and are intended for implantation only with bone cement.
New unicondylar knee all-poly tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The overall material and design of the all-poly components are based upon the existing Genesis Unicompartmental tibial implants and the existing Mod II Knee System implants cleared under 510(k) Notifications K912735 and K760245, respectively.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study design, or ground truth for a medical device. The document is a 510(k) summary for a knee prosthesis, primarily focusing on its intended use, description, and substantial equivalence to existing devices. It does not contain any data related to performance metrics or studies.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.