Standard
ASTM F2083
Standard Specification for Knee Replacement Prosthesis
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. 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…
Our Testing Services
When choosing a medical device testing laboratory to perform evaluations, there are four key elements to consider:
- Interaction with a senior engineer to review the intricacies of the device and to ensure the proposed testing will address corporate goals and objectives
- Accurate implementation of the testing standard(s)
- Comprehensive reporting of the materials, procedures and data to align with ASTM/ISO and USFDA reporting requirements
- Regularly scheduled and documented verification, calibration and maintenance of testing equipment
ORL does all of the above, always has, and laid the groundwork for many of today’s active standards!
