X-spine Systems, Inc. is a next-generation spinal implant company dedicated to advancing spinal implant technologies that improve surgery outcomes and optimize surgeon experience.
An FDA registered and ISO 13485 compliant organization, X-spine performs biomechanical testing of all of its components to ASTM F1717 and/or F1798 standards. Explained David Kirschman, X-spine President, “We conduct biomechanical testing for both quality control and product development, looking for peak load, yield, yield load, percent of elongation and elasticity.”
Initially, X-spine outsourced all of its biomechanical testing. As production ramped up, however, it was cumbersome and inefficient to rely on outside services, especially for ad hoc testing. Kirschman decided to bring some testing in-house.
After determining that electromechanical screw based machines were appropriate for his needs, he looked at a number of different brands online. He selected the ADMET eXpert 5601 tabletop machine with an eP2 Digital Controller, a standalone touch panel controller that offers a balance between performance and simplicity, a 1.1kN load cell and GaugeSafe Data Exchange software.
The setup is simple and quick, and it is readily available for the ad hoc testing that Kirschman was looking for. “The nice thing about the ADMET is it’s a very simple machine with the computer/controller built in. So, a quality control inspector can come in and operate it efficiently and easily to run an individual part for a static test.”