Standard Specification for Total Knee Prosthesis
|Publication Date:||1 November 2004|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110° of flexion to high flexion. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F 1672.
Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.
This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined.
Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.