Bone Plate, Bone Screw, and Fixation Device Testing

Accelerate your medical device development with comprehensive testing that validates performance and supports regulatory approval. Our bone plate, bone screw, and fixation device testing delivers the data you need for FDA submissions while maintaining the highest standards of patient safety.

What is Bone Plate, Bone Screw and Fixation Device Testing at Element?

Medical device testing validates the mechanical strength, durability, and safety of orthopedic implants and fixation devices. At Element, we provide comprehensive testing services that evaluate static and dynamic properties of bone plates, screws, and fixation devices through established ASTM standards and custom protocols.

Element life sciences testing expert in lab

What Can Element Offer You For Bone Plate, Bone Screw and Fixation Device Testing?

Components and products we test

Element evaluates a comprehensive range of internal and external fixation devices, including bone plates and screws, intramedullary rods, and external fixators. Our capabilities cover standard configurations and custom designs, supporting your specific development needs. You'll benefit from our expertise across the full spectrum of orthopedic devices, including specialized components like bone anchors, sutures, and complex fixation assemblies.

Key tests offered

Our comprehensive testing program examines mechanical properties through static bending, tension testing, torsional evaluation, and fatigue testing up to 1,000,000 cycles. We validate insertion torque, axial pullout force, and self-tapping performance. Your devices undergo rigorous testing in accordance with industry standards, providing you with reliable data for regulatory submissions and product validation.

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.

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 fixation device.

Methods and solutions offered

We combine industry-standard testing protocols with customized approaches to meet your unique requirements. Our labs offer complementary services, including particulate testing, porous coating evaluation, and in-house project management. You'll receive comprehensive documentation and expert guidance throughout the testing process, streamlining your path to market approval.

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.

Internal Fixation Devices:

Bone Plates (ASTM F382 & F384)
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 guiding these specific angled designs.

Bone Screws (ASTM F543)
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).

Which labs offer this service

Our Cincinnati laboratory serves as the global Center of Technical Excellence for medical device testing, equipped with state-of-the-art facilities and expert staff. The facility specializes in orthopedic device testing, offering you access to specialized equipment and technical expertise developed through years of industry experience. Beyond that, Element operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Advanced regulatory support

Our testing programs align with FDA requirements and international standards, providing you with comprehensive documentation and expert guidance throughout the submission process. You'll work with experienced professionals who understand the complexities of medical device regulations and can help navigate the approval process efficiently.

Standards we test to and components we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!

ASTM F382 for bone plates
ASTM F384 for angled bone plates
ASTM F543 for bone screws
ASTM F1541 for external fixation devices
For projects with different requirements, our experts can help identify the most appropriate standard for testing. We can also provide guidance and support for testing to regulatory requirements, including the FDA 510K.

Your Challenges, Our Solutions

Streamlining regulatory compliance

Your path to FDA 510(k) approval becomes clearer with our comprehensive testing programs. We provide complete data packages that meet regulatory requirements, supported by expert guidance throughout your submission process.

Simplifying testing standards

Navigate complex ASTM requirements with confidence through our expert support. We help identify the most appropriate standards for your specific devices, create clear testing protocols, and deliver results that satisfy regulatory requirements.

Complete performance validation

Access comprehensive mechanical testing that validates your device performance under real-world conditions. Our advanced capabilities evaluate both static and dynamic properties, providing thorough assessment across all critical parameters.

Custom requirements

Your unique device configurations receive tailored testing approaches that maintain regulatory compliance while addressing specific design requirements. We develop custom testing protocols that account for innovative features and specialized applications, supporting your product development goals.