Intramedullary Rods (IM) are metal rods forced into the medullary cavity of a bone. IM rods are used to align and stabilize fractures of long bones. The IM rods are inserted into the bone marrow canal in the center of the bone and stabilize the fracture with bone screws. This device is commonly used when bone fractures are located in the upper arm or leg (Humerus, Tibia, Fibula and Femur). Most often rods placed in long bones to repair a fracture can be left in the patient after full recovery therefore it is critical that medical device manufacturers verify the strength of the implant. ASTM F383 and ASTM F1264 were developed to standardize the quality testing of this device and verify that the product will not fail post-surgery. ASTM F383 was first published in 1973 and has since been withdrawn on account of ASTM F1264′s development.
ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices outlines four test procedures:
Annex A1 -Test Method for Static Four Point Bend
Annex A2 -Test Method for Static Torsional Testing of Intramedullary Fixation Devices
Annex A3 -Test Method for Bend Fatigue Testing of Intramedullary Fixation Devices
Annex A4 -Test Method for Bend Fatigue Testing of IMFD Locking Screws
ADMET offers multiple mechanical force testing systems configured to meet and exceed the ASTM F1264 test standard. There are a range of systems specific to IMFD devices that can perform all or some of the required tests depending on end user requirements. All of the systems are controlled with ADMET’s proven MTESTQuattro testing software that automatically performs each test according to ASTM and ISO standards, as well as custom test procedure.