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. KMT 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

Standard #

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