We help our clients gain regulatory approval for osteosynthesis 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 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 Plates
Describes 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 System
Describes 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.
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.
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.
Specification and Test Method for Metallic Bone Staples
Constant 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 Devices
Identifies 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 Devices
Describes 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 Screws
Describes 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 Screws
Describes 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.