1.1 This test method covers a laboratory based in-vitro method for evaluating the mechanical performance of materials and devices being considered for replacement of the tibio-femoral joint in human knee joint replacement prostheses in mobile bearing knee systems.
1.2 Mobile bearing knee systems permit internal external rotation to take place on one or both articulating surfaces. Some designs place physical limits or stops to the amount of rotation. Other designs may have increases of resistance force with rotation.
1.3 It is the intent of this test method to describe test parameters that define physiologically based performance requirements for mobile bearing knee systems intended to replace the tibiofemoral joint of the human knee. This test method is applicable for both total knee and unicompartmental knee replacements.
orthopedics; arthroplasty
may be adopted by FDA; useful in research, development, and quality control of mobile bearing knee designs
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 02-09-2007
Technical Contact: Leslie Gilbertson
Item: 001
Ballot: F04.22 (07-01)
Status: Will Reballot Item
Item: 001
Ballot: F04.22 (07-03)
Status: Negative Votes Need Resolution
Item: 015
Ballot: F04 (08-01)
Status: Ballot Item Approved