Lumbar Total Facet Prosthesis Testing
The ATS Family of Companies (FoC) provides spine implant medical device testing according to the ASTM F2694 standard. A total facet prosthesis replaces a deficient facet in the lumbar spine, alleviating pain and supporting spinal health and motion.
Prosthetic facets have multiple design options, such as ball-and-socket articulating joints and metallic load-bearing surfaces. The wide range of metals, polymers, and ceramics used to create prostheses requires complex testing.
To ensure a prothesis’s long-term function, the ATS FoC follows the recommendations of ASTM standard F2694 for cyclic loading procedures to study the wear, function, and kinematic behavior of prostheses.
ASTM F2694 Procedure
ATS FoC experts can perform the test in temperature-controlled, sterilized chambers, using a mounting component, like a clamp or fixture, to secure the prosthesis. First, we flood the testing chamber with a solution maintained at 37°C. Next, we subject the prosthesis to various worst-case scenarios that anticipate harsh in vivo conditions, including a compressive force that simulates the shear load in a spine at a frequency ≤2 Hz. We can maintain a magnitude of force (±5%) in the desired range of motion for the facet.
During the test, we can subject the facet to specified motions and loads:
- Flexion Loading/Extension Loading
- Lateral Bend Loading
- Axial Rotation Loading
Total Facet Prosthesis Analysis
Throughout the procedure, we take geometric measurements of all relevant functional surfaces of the test specimens to record how the product changes with wear. Our analysis includes additional factors, such as:
- Range of Motion (ROM)
- Load data
- Failure modes and deformations
- Filtered particle analysis
- Net wear
- Interval net wear rate
- Net volumetric wear
Medical Device Testing Quality Assurance
The ATS FoC empowers clients to make informed business decisions through our four broad service areas: consulting engineering, calibrations, testing, and analysis. We operate multiple ISO 17025-accredited labs across the continental U.S., which enables our quick turn-around rate as we meet our clients’ needs. Our experts regularly work with sophisticated technology to deliver precise and reliable results according to regulatory requirements and industry standards.
Please call +1 (888) 287-5227 or complete a request form for ASTM F2694 testing from ATS today.
