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.
Bone Screw Testing for Torsional PropertiesMedical bone screws are tested for torsional yield strength, maximum torque, and breaking angle. The bone screw is placed in a holding device such as a split collet. The associated driver instrumentation is used to apply a torque at a constant rate of rotation until failure. Torque and rotation data is collected. | |
Bone Screw Testing for Driving TorqueMedical bone screws are tested for the torque required to drive the screw into a standardized bone-analogue test block. The bone screw is inserted into the test block using appropriate driver instrumentation at a constant rate of rotation until reaching a specified depth. Torque and rotation data is collected. Testing the removal torque is optional. | |
Bone Screw Testing for Axial Pullout LoadMedical bone screws are tested to determine the load required to pull the screw out from a standardized bone-analogue. A fixture is used to apply an axial tensile load on the screw at a constant rate of displacement until screw pullout or failure. | |
Bone Screw Testing for Self-Tapping PerformanceSelf-tapping bone screws are tested to determine the load required to engage the self-tapping feature of the bone screw. The self-tapping screw is inserted into a standardized bone-analogue test block at a constant rate of rotation and steady rate of axial compression until the self-tapping feature engages with the test block. | |
Specifications of Bone ScrewsDescribes the classifications of different varieties of medical bone screws based on major and minor dimensions, thread forms, thread pitch, and driver connections. | |
Testing for Spinal Implant Constructs in a Vertebrectomy ModelThis standard includes three static test methods (compression bending, tensile bending, and torsion) and a compression bending fatigue test. These test methods may be applied to cervical, thoracolumbar, lumbar, and lumbosacral spinal implant constructs. The spinal implant construct may include bone screws, rods, set screws, hooks, transverse elements, cables, wires, bolts, and/or plates. The spinal implant construct is assembled into specified test blocks to simulate a vertebrectomy model. Spinal implant assemblies are tested accordingly to determine yield load, stiffness, and strength. Fatigue tests shall reach a run-out of 5 million cycles or failure. | |
Static and Dynamic Testing for Interconnection Mechanisms and Subassemblies in Spinal ImplantsThe interconnection mechanisms of spinal arthrodesis implants are tested for uniaxial static and fatigue strength, and resistance to loosening for the purpose of mechanical and design evaluations. The directions of loading shall follow those relevant to which the interconnection is designed to provide resistance to loading. Fatigue tests shall reach a run-out of 2.5 million cycles or functional failure. | |
Static and Dynamic Testing for Intervertebral Body Fusion Devices The intervertebral body fusion device is evaluated for mechanical comparison through a series of static and dynamic testing under axial compression, shear-compression, and torsion. Test blocks are customized to fit the geometry of the sample device tested. Fatigue tests shall reach a run-out of 5 million cycles or functional failure. | |
Specifications and Testing for Spine Screws, Plates, and RodsThis standard describes the specifications and the static and fatigue bending test methods for spine screws, rods, and plates. Test set-up follows a four-point bend assembly for rods and plates. Spine screws follow a cantilever set-up. The fatigue strength of each spinal fixation component is determined by cycling to a run-out of 2.5 million cycles. It is recommended that spine screws also be tested for torque strength, driving torque, and pullout resistance as described in ASTM F543. | |
Axial Compressive Subsidence TestingThe spine device is positioned between two polyurethane foam test blocks customized to fit the geometry of the device. A static axial compressive load is applied to measure the deflection into the test blocks. Device stiffness is collected from similar test methods using metallic test blocks (ASTM F2077 or ASTM F2346) and is used to calculate the propensity of the device to subside. | |
Static and Dynamic Testing for Spinal DiscsThe intervertebral spinal disc replacement device is evaluated for mechanical comparison through a series of static and dynamic testing under axial compression, shear-compression, and torsion. Test blocks are customized to fit the geometry of the sample device tested. Fatigue tests are set for a run-out of 10 million cycles or until functional failure. | |
Static, Dynamic, and Wear Test Methods of Extra-Discal Single Level Spinal ContructsExtra-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. | |
Testing for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implants in a Vertebrectomy ModelThis standard includes three static test methods (compression bending, tensile bending, and torsion) and two dynamic test methods (compression bending fatigue and torsion fatigue) that may be applied to occipital-cervical and occipital-cervical-thoracic spinal implant constructs. The spinal implant construct may include bone screws, rods, set screws, hooks, transverse elements, cables, wires, and/or bolts. The spinal implant construct is assembled into specified test blocks to simulate a vertebrectomy model. Spinal implant assemblies are tested accordingly to determine their yield load, stiffness, and strength. Fatigue tests shall reach a run-out of 5 million cycles or failure. | |
Standard Practice for Inspection of Spinal Implants undergoing TestingA 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. | |
Sacroiliac Joint Fusion Device TestingIn-line and transverse sacroiliac joint (SIJ) fusion devices follow a series of static and fatigue test methods. In-line SIJ fusion devices shall undergo shear and/or torsion testing (Annex A1). Transverse SIJ devices shall undergo cantilever bending testing, pullout testing, torsion testing, and driving torque testing (Annex A2). All fatigue testing shall be carried out for 2.5 million cycles or until functional failure of the device. | |
Intra-operative Durability Testing of Intervertebral Body Fusion DevicesThis test method evaluates the impact durability of the intervertebral body fusion device by simulating surgical impaction. The impact testing is done between a set of polyurethane foam blocks and/or onto a rigid block to measure the impact resistance of the device. Two stair-step impact loading options are given and can be applied to either test method. | |
Fatigue Testing for Spinal Assemblies using Anterior SupportIn this test method, spinal implant assemblies (for fusion or motion preservation) using anterior support are tested in fatigue to reach a run-out of 5 million cycles or failure. The spinal implant assembly is set-up with specified UHMWPE test blocks and springs. | |
Spinal Disc Wear TestingSpinal disc wear testing is performed according to standard loading and displacement parameters for the cervical and lumbar spine. Generally, six samples are tested up to 10 million cycles with two load soak stations using the OIC’s AMTI hip simulator. Wear is determined through gravimetric analysis at various intervals throughout the test (ISO 14242-2). Test fluid samples may be collected and examined for wear particle characterization as described in ASTM F1877 and ASTM F561. Wear patterns may be evaluated further using microscopic imaging. This standard may be customized to suite the design and needs of your spinal device. ASTM F2423 describes similar wear test methods for spinal disc replacements. | |
Spinal Disc Impingement-Wear Testing under Adverse Kinematic ConditionsThe traditional wear test procedure for a spinal disc replacement is adjusted to apply and evaluate wear under adverse impingement conditions using the OIC's AMTI hip simulator. Wear is measured and analyzed at shorter intervals of 125, 250, and 500 thousand, and at the end of the test at 1 million cycles. Test fluid samples may be collected and examined for wear particle characterization as described in ASTM F1877 and ASTM F561. Wear patterns may be evaluated further using microscopic imaging. This standard may be customized to suite the design and needs of your spinal device. |