Table 1

Examples of standard material specifications and test methods relevant to spinal implant devices

Material specifications
ASTM F67Unalloyed Titanium for Surgical Implant Applications
ASTM F75Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
ASTM F136Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
ASTM F648Ultrahigh Molecular Weight Polyethylene (UHMWPE) Powder and Fabricated Form for Surgical Implants
ASTM F2026Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Spinal fusion systems
ASTM F1717Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F1798Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F2193Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F2706Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
ISO 12189Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support
Intervertebral body fusion devices (cages)
ASTM F2077Test Methods for Intervertebral Body Devices
ASTM F2267Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
Total disc replacements
ASTM F2346Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
ASTM F2423Standard Guide for Functional, Kinematic and Wear Assessment of Total Disc Prostheses
ISO 18192-1Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
Other nonfusion devices or systems
ASTM F2624Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
ASTM F2694Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses