Spinal Implants Testing Services

At Element we test the full spectrum of spinal implant devices, from traditional fusion devices used to treat fractures, disc compression, and deformities to cutting-edge expandable cages and hybrid systems. Our testing capabilities cover both standard components and innovative designs using additive manufacturing technology. Non-fusion devices we test are specifically designed to maintain spine mobility when relieving pressure.

Our comprehensive testing program includes static and dynamic testing across multiple loading modes: axial, torsional, shear, flexion/extension, bending, lateral bending, and axial rotation. We perform specialized testing for subsidence evaluation and wear analysis.

Spinal Cage Testing

• Static and Dynamic Testing (ASTM F2077)
• Load Induced Subsidence Testing (ASTM F2267)

Spinal Construct Testing

• Spinal Implant Constructs in a Vertebrectomy Model (ASTM F1717)
• Occipital-Cervical and Occipital-Cervical-Thoracic Constructs (ASTM F2706)
• Subassemblies Used in Spinal Arthrodesis Implants (ASTM F1798)

We provide precise test setups using custom-manufactured test pucks that exactly match your device profiles. Our in-vitro testing includes saline solution environments for SEM evaluation and mass-loss analysis to characterize wear rates.

Spinal Cage Testing Methods:

• Static and Dynamic Testing (ASTM F2077)

  This method tests mechanical properties of spinal cages, including static and dynamic compression, torsion, and shear. Test pucks are made to mimic the device profile, then subjected to static or dynamic testing. The dynamic testing is done in saline solution to evaluate wear and particulate generation. Mass-loss evaluation tracks wear rates.

• Load Induced Subsidence Testing (ASTM F2267)

  This test measures the likelihood of spinal cage subsidence under compressive forces. The device is placed between polyurethane test blocks and loaded until failure is achieved, evaluating its durability.

Spinal Construct Testing Methods:

• Spinal Implant Constructs in a Vertebrectomy Model (ASTM F1717)

  This test evaluates static and dynamic performance of spinal implant constructs. Plates or pedicle screw systems are loaded in compression, torsion, and tension. Dynamic compression testing requires a dynamic compression curve consisting of multiple failures and at least two run-outs to 5 million cycles under a constant axial load, ensuring device reliability under stress.

• Occipital-Cervical and Occipital-Cervical-Thoracic Constructs (ASTM F2706)

  Additional static and fatigue testing for occipital-cervical and occipital-cervical-thoracic spinal constructs, providing further evaluation for these specialized devices.

• Subassemblies Used in Spinal Arthrodesis Implants (ASTM F1798)

  This test assesses the fatigue strength and loosening resistance of subassemblies used in spinal implants, such as rods, hooks, and screws. Testing includes static A-P load (Fx), transverse load (Fy), axial gripping capacity (Fz), transverse moment (My), and axial torque (Fz)to ensure durability and functionality.

Our team 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. 

We offer unique testing capabilities for hybrid and standalone devices that combine cage and screw systems. Our expertise extends to testing additively manufactured spinal implants, including both design and material qualification requirements. When testing dynamically, we conduct in-vitro testing using saline solution, enabling detailed SEM evaluation of particulate generation and comprehensive mass-loss analysis to characterize wear rates during testing.