Search Results

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.

Ask a specific question about this device