Spine Device Testing

We can help you gain regulatory approval for your spine devices

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Spinal Disc Wear Test

Wear performance of cervical and lumbar prostheses is assessed via loading and displacement parameters as specified in ISO 18192. Six samples are tested for 10 million cycles through the use of OIC’s AMTI hip simulator. Wear is measured through gravimetric analysis following ISO 14242-2.
Fatigue Testing of Spinal Assemblies Using Anterior Support

Anterior spinal implant constructs are subjected to fatigue compression tests to evaluate the implant assembly. Vertebrae are simulated with UHMWPE test blocks. Testing is stopped after 5 million cycles, or failure of the spinal implant construct.
Test Method for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implants in a Vertebrectomy Model

Describes static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model which is simulated with a large gap between two UHMWPE test blocks adjoined by the implant assembly. Static load testing is performed using three different tests including: compression bending, tensile bending, and torsion testing. Fatigue tests include: compressional bending fatigue and torsional fatigue. Fatigue components are tested for 5 million cycles, or until failure.
Axial Compressive Subsidence Testing

Describes axial compressive subsidence testing of an intervertebral body device into two polyurethane foam blocks simulating bone substrate. The blocks are designed to mate with the geometry of the device, similar to how the device mates with vertebral end plates. An axial load is applied and displacement is recorded for all 5 samples.
Specification and Test Methods for Fixation Devices of Spinal Skeletal System

Specifications for metallic spine screws, spine plates and spine rods are defined in this standard, as well as the static and fatigue bending strength test methods. Static and fatigue tests are intended to mechanically characterize device design, not define performance or predict consequences of use.
Test Methods for Intervertebral Body Fusion Devices

Describes static and fatigue testing of intervertebral body fusion devices in axial, lateral, and compression-shear orientations, to characterize the structural integrity of the device. Samples are tested between simulated vertebral bodies, made of polyacetal blocks for dynamic loading, and stainless steel blocks for static loading. The blocks are designed to mate with the geometry of the device, similar to how the device mates with vertebral end plates. Samples are tested for 5 million cycles, or until failure.
Static and Fatigue Testing of Interconnections and Subassemblies in Spinal Arthrodesis Implants

Describes test methods to evaluate uniaxial static strength, fatigue strength and resistance to loosening of interconnection mechanisms of spinal arthrodesis implants. Mechanical static testing is performed to failure and fatigue testing is performed for components to a maximum of 2.5 million cycles. Load is applied to interconnections in relevant directions as outlined by the ASTM standard.
Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Describes static and fatigue testing of spinal implant assemblies in a vertebrectomy model which is simulated with a large gap between two UHMWPE test blocks adjoined by the implant assembly. Compression bending, tensile bending, torsion testing, and compression bending fatigue test methods are provided as well as guidelines for measuring displacements, determining yield load and evaluating stiffness and strength of the spinal implant assembly.
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