We can help you gain regulatory approval for your spine devices
OIC offers a broad range of static, dynamic, computational, and wear testing services for spinal fixation and disc arthroplasty devices. All of our test procedures follow international test standards as described below.
Our engineering team is active in the ASTM spinal device standards committee to ensure the latest industry best-practices are applied to your test. If a non-standard test is needed, our engineering team will develop and incorporate modifications to suit your specific device and data needs.
Having a strong foundation in clinical research provides you with the additional value of a clinically-relevant test procedure. We pride ourselves on the ability to meet a customer’s specific needs with a wholly unique, tailored solution.
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.
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 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.
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.
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.
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.
Standard Test Methods for Sacroiliac Joint Fusion Devices
Describes static and fatigue testing of in-line and transverse sacroiliac joint (SIJ) fusion implants. In-line SIJ fusion implant test methods characterize the mechanical performance under shear and torsion by testing between simulated vertebral bodies, made of polyacetal blocks for dynamic loading, and stainless steel blocks for static loading. Transverse SIJ implant test methods evaluate the torsional strength, bending strength and pullout resistance of the implant inserted in Grade 20 polyurethane foam. Fatigue components are tested to 2.5 million cycles, or until failure.
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.
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.