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Spine Device Testing

We help our clients gain regulatory approval for spine devices

We offer a broad range of static, dynamic, and computational testing services for spine devices. All of our test procedures follow international test standards as described below.

Our engineering team is active in ASTM and ISO arthroplasty standards committees 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.

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Torsional Properties of Bone Screws
Describes the method to determine the torsional yield strength, maximum torque, and breaking angle for medical bone screws. The torque applied during this test method is not intended to predict the torque encountered clinically.
Driving Torque
Describes the method to determine the torque required to drive a medical bone screw into a bone-analogue material. The insertion torque applied during this test method may not be representative of the torque encountered clinically.
Pullout Resistance of Bone Screws
Describes the method to determine the axial pullout strength of a medical bone screw from a bone-analogue material. The axial force applied during this test method may not be representative of the pullout resistance encountered clinically. This test method can be modified based on the materials being testing and the intended application of the device.
Self-Tapping Performance of Bone Screws
Describes the method to determine the compressive force required to engage a self-tapping medical bone screw into a bone-analogue material. The self-tapping bone screw is turned in the fastening direction while the axial compressive force is increased at a defined rate until screw engagement within the bone-analogue occurs.
Specifications of Bone Screws
Describes the classifications of different varieties of medical bone screws based on major and minor dimensions, thread forms, thread pitch, and driver connections.
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.
Static and Dynamic Test Methods for Spinal Artificial Discs
Spinal artificial discs are tested under axial compression, compression-shear, and torsion to determine static and dynamic mechanical behaviour for device comparison. Dynamic testing is carried out for 10 million cycles, or until failure. Additional testing may be performed on artificial spine discs to address implant resistance to expulsion and implant wear resistance as per ISO 18192-1 and ISO 18192-2.
Static, Dynamic, and Wear Test Methods of Extra-Discal Single Level Spinal Contructs
Extra-discal single-level motion preserving spinal constructs are tested under static, dynamic, and wear conditions that evaluate implant designs in a functional manner. Wear is tested in a fluid medium, then assessed through gravimetric and dimensional analysis. Wear debris may be analyzed through particle analysis as per ASTM F1877 and ASTM F561.
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 Practice for Inspection of Spinal Implants undergoing Testing
A guideline for assessing and recording notable changes in spinal implant characteristic such as cracking, plastic deformation, and surface defects as a result of testing. This practice provides a standardized analysis method to identify mechanical failures in spinal implants from test methods F1717, F1798, F2077, F2267, F2346, F2624, F2706, F2193, F2423, F2789, F2694, and F2790.
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.
Intra-operative Durability of Intervertebral Body Fusion Devices
A test method to evaluate the durability of intervertebral body fusion devices when subject to impaction forces during surgical implantation from instrumentation. Additional test methods that provide mechanical evaluation and comparison of intervertebral body fusion devices are ASTM standards F2077, F2267, and expulsion testing.
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.
Total Intervertebral Lumbar Spinal Disc Impingement-Wear Test under Adverse Kinematic Conditions
Wear of intervertebral lumbar spinal disc prostheses are tested under simulated adverse kinematic conditions using OIC's AMTI hip simulator. Six samples are tested up to 10 million cycles and wear is measured through gravimetric analysis following ISO 14242-2.
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