ASTM F2083-12 Test Standard for Knee Replacement Prosthesis

This standard is intended to cover all commonly used generic knee prosthesis types used to provide functional articulation. This includes both fixed and removable bed variants and total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses for primary or revision surgeries. Although a patellar component can be considered an integral part of a TKR, the detailed description of this component is excluded here as it is provided in specification F1672.

The scope of this standard includes interchangeable components of modular designs, such as tibial articulating surfaces and all components that are labeled with or can be used with cement, regardless of whether the same components can also be used uncemented.

This standard aims to provide basic definitions of materials and prosthetic geometry. In addition, these features determined to be important for the in vivo performance of the prosthesis are identified. However, compliance with this specification alone does not define a device that will provide adequate clinical performance.

Excludes hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; and patellofemoral prostheses. Devices designed for special applications are also excluded.

Values ​​stated in SI units should be accepted as standard.

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