Medical bone plates and screws, along with various other internal and external fixation devices are used throughout the body for a variety of trauma conditions and disorders
Element’s team of Engaged Experts provides destructive testing on these devices in accordance with a variety of ASTM standards, as well as client specific test protocols.
Typical devices tested include:
- Bone plates
- Bone screws
- Spinal Fixation Assemblies
- Intramedullary Rods and Nails
- External Fixation Devices
Internal Fixation Devices
Element provides a comprehensive suite of testing solutions for internal fixation devices, from bone plates and screws to intramedullary rods and nails. Common tests performed include static bending, tension, and torque along with a variety of fatigue tests.
Bone Plates (ASTM F382 & F384): Metallic bone plates are tested to determine both static and dynamic bending properties. Samples are loaded into a 4 point bend test fixture and either bent to failure, or cycled to a run-out of 1,000,000 cycles. Angled plates are tested in the same manner, with ASTM F384 providing guidance for these specific angled designs.Bone Screws (ASTM F543): Metallic bone screws must withstand a battery of testing as prescribed in the various annexes of ASTM F543. This testing includes torsional properties, insertion/removal torque, axial pullout force, and self-tapping performance (if applicable).
External Fixation Devices
Due to the modularity of many external fixators, there are a variety of test methods available depending on the application of your specific assemblage. Element’s team can assist you in determining the most appropriate test methods for your device.
External Skeletal Fixation Devices (ASTM F1541): This specification outlines how to perform static and dynamic testing on external fixation devices to determine the mechanical properties of the device. ASTM F1541 defines the test procedures for various assemblages, including:
- In-plane compression of ring elements
- Anchoring pins
- Schanz Screws
Discover more about Element
Our Cincinnati laboratory is Element's global Center of Technical Excellence for medical device testing.
Maciej has nearly 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.
Element offers comprehensive capabilities to assist in determining root cause failure.
Meet with our Engaged Experts during the American Academy of Orthopaedic Surgeons' Annual Meeting in Orlando.