ASTM F2789 โ Mechanical and Functional Characterization of Nucleus Devices
The ATS Family of Companies (FoC) provides a range of mechanical and functional tests for characterizing nucleus devices. A nucleus device can replace or augment the nucleus pulposus in an intervertebral disc without replacing the entire disc. This procedure aims to restore movement and loads to a diseased spinal level without usingย vertebral fusion devices.
A relatively new solution to degenerative disc disease, nucleus devices require careful and thorough testing. The ASTM standard helps implant manufacturers:
- Compare devices with different designs and materials
- Quantify static and dynamic properties of nucleus devices
- Quantify the performance of nucleus devices
Static and Dynamic Testing
As a third-party provider of medical device testing, the ATS FoC lends its credible reputation to manufacturers ready forย in vitroย testing. Our medical device testing lab houses powerful equipment for a variety ofย mechanical tests. We can perform the static and dynamic tests called for by ASTM F2789:
- Axial Compression Test
- Axial Torsion Test
- Shear Test
- Flexion/Extension Test
- Lateral Bending Test
Clients can select the tests relevant to their devices and request additional controls. For example, we offer testing in force/moment control or displacement/angle control until functional failure or run out. Ourย dynamic testsย can combine flexion/extension, axial rotation, axial loading, and lateral bending motions. Additionally, we can carry out dynamic tests in ambient, dry conditions or in a saline bath held at 37หC.
For more information on our static and dynamic tests, seeย ASTM F2346,ย ASTM F2423, andย ISO 18192-1.
Function Tests
ATS FoC can also perform function tests included in ASTM F2789. For instance, we can determine the lifting force of a hydrated nucleus replacement device after fluid absorption. Following ASTM F2267, we explore the deviceโs subsidence and stiffness. Finally, we can anticipate mechanical changes due to age-dependent materials. Upon request, our experts may provide additional chemical analysis with the following methods:
- Fourier Transform Infrared Spectroscopy
- Differential Scanning Calorimetry (DSC)
- Gel Permeation Chromatography
ASTM F2789 Analysis
Our experts provide rigorous testing and thorough analysis, includingย particulate analysis,ย wear analysis, and degradation analysis. We can inspect nucleus devices for mechanical failure, measure migration, and detail the functional failures to provide manufacturers with precise and accurate information.
Why Choose the ATS FoC?
Theย ATS FoCย consists of expert engineers and technicians at many locations nationwide. With multiple A2LA-accredited labs capable of chemical analysis, mechanical testing, and more, we help medical devices reach the market faster. Our seasoned experts can test your medical implant for regulatory compliance and performance.
Call +1 (888) 287-5227 or complete the form on this page to request nucleus device testing according to ASTM F2789.
