Orthopedic Knee Implant Testing
The world-renowned orthopedic testing laboratories at JTL America provide a variety of testing solutions for the medical/orthopedic industry. This includes knee implant testing for FDA and regulatory approval.
In addition to performing these tests, our team of experts will guide you through the required tests for your device and continue providing support to address any questions that arise during the regulatory evaluation process.
Here’s a list of commonly tested knee replacement components below.
- Taper connections
- Tibial trays and liners
- Femoral components
- Unicondylar components
Knee Implant Testing Services
Mechanical testing for large joints such as knee implants is multifaceted, with standards to address fatigue properties of load bearing members, disassembly forces between mating components, range of motion between articulating and sliding components, and wear debris generated from relative motion.
Here’s a list of specific testing services for knee replacement devices.
Knee Implant Testing Standards
Below is a list of knee implant testing standards offered by our laboratories.
American Society for Testing and Materials (ASTM)
ASTM F1223 – Standard Test Method for Determination of Total Knee Replacement Constraint
ASTM F1800 – Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F2009 – Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
ASTM F2345 – Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
ASTM F2777 – Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
The experts at JTL America specialize in testing large joints such as hip and knee replacement implants, as well as other orthopedic devices.
The test reports prepared by our experts are routinely used for submission to the FDA as well as global regulatory bodies across Europe, South America, and Asia.
We provide testing on these devices as well as continued support following your device’s submission for regulatory approval.
If you’d like to know more about our knee implant testing services, contact us for a fast quote.