Material Testing for Medical Devices for the Spine

While numerous standards exist for common devices such as cages, plates, and screws, the pace of device development in spine far exceeds the development of standards that govern how they are tested. Combined with evolving requirements from regulatory bodies, bringing a new spinal implant to market is a daunting task. JTL America can help. Contact us to discuss a comprehensive yet streamlined approach to testing your new spinal implant. Some commonly tested devices are listed below:

  • Cervical and lumbar plating systems
  • Lumbar pedicle screws
  • OCT plate and screw systems
  • Spinal spacers (IBFD and VBR)
  • Interspinous spacers
  • Don’t see your test here? Contact us to discuss your requirements.
ASTM Standards Test Name
F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1798 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F2077 Test Methods For Intervertebral Body Fusion Devices
F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
F2706 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model