We help our clients gain regulatory approval for osteosynthesis and trauma medical devices
We offer a broad range of static, dynamic, and computational testing services for fracture fixation and osteosynthesis devices. All of our test procedures follow international test standards as described below. Our testing protocols cover trauma-induced scenarios to ensure the robustness and efficacy of osteosynthesis devices.
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.
Test Method for Metallic Bone PlatesDescribes single cycle bending test and fatigue test methods of metallic bone plates. Depending on the application of the bone plate, certain tests may be applied to evaluate different strength characteristics required for in vivo efficacy. | |
Test Method for Metallic Angled Devices used in Internal Fixation of Skeletal SystemDescribes a test method specifying mechanical tests of metallic angled devices important to in vivo performance, such as, single cycle compression bending and bending fatigue methods. Depending on the application of the angled device, certain tests may be applied to evaluate different strength characteristics required for in vivo efficacy. | |
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. | |
Specification and Test Method for Metallic Bone StaplesConstant amplitude bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending are the four available test methods for evaluating metallic bone staples used in the internal fixation of the musculoskeletal system. Specifications on the characterization and mechanical function of metallic bone staples are also covered. | |
Test Methods for External Skeletal Fixation DevicesIdentifies several test methods for testing both individual components, such as external fixator connectors and skeletal fixator joints, subassemblies such as ring elements, and full external fixation devices. | |
Test Methods for Intramedullary Fixation DevicesDescribes four standard test methods: static four-point bend, static torsion, bending fatigue test, bending fatigue test for locking screws. Not all tests outlined in this standard are applicable/required, but based on the intent of the device, certain tests may be applied to evaluate different strength characteristics required for in vivo efficacy. | |
Fretting Corrosion of Plates and ScrewsDescribes the method to determine material loss due to cyclic fretting corrosion between screw head and plate hole countersink junctions of devices used for osteosynthesis. Mass loss of the plates and screws and chemical analysis of the solutions are evaluated to determine the amount of fretting corrosion that occurred. | |
Test Methods for Absorbable Plates and ScrewsDescribes the mechanical characterization and test methods for absorbable plates and screws made from hydrolytically degradable polymer resins or resin composites for orthopaedic internal fixation. Test methods aim to assess the performance-related mechanical properties when applied to conditions of pretreatment, temperature, humidity, and testing machine speed. The standard may not be applicable to all forms of absorbable plates and screws. |