Safe Orthopaedics receives 510k approval from the FDA for the sale of its 2nd Generation of SteriSpineTM PS in the United States
- Success of the 2nd generation SteriSpineTM PS range among surgeons in marketed areas
- New patent in Japan for the Oak screw implant belonging to SteriSpineTMPS range
Eragny-sur-Oise, France, August 10th à 6.00 PM CEST – Safe Orthopaedics (FR0013467123 - ALSAF), a company specializing in the design and marketing of ready-to-use technologies for spinal surgeries, delivering the safest treatment of spinal fractures urgently treated, is annoucing today the 510k approval from the American Regulatory Agency Food and Drug Administration (FDA), for the sale its 2nd Generation of SteriSpineTM PS in the United States.
Developed in 2010, SteriSpineTM PS is the first technology of pedicle screws combined to a ready-to-use instrumentation (single use and sterile) worldwide. As more than ten thousand surgeries have been performed, Safe orthopaedics has been announcing in 2019 the launch of its 2nd generation. Significantly thinner, more rigid and still radiolucent, SteriSpineTM PS 2nd generation enables the surgeon to perform the surgery in an even more mini-invasive approach, and can be used on a wider number of spine pathologies.
Safe Orthopaedics has been enhancing business development of SteriSpineTMPS 2nd generation since the beginning of 2020. In the first quarter, technology was delivered to Japan, and in the second quarter, it was available to several Europeans countries and in Asia Pacific area. At the end of the year, all direct French, English and German direct customers will have been converted.
Following this 510k approval from the FDA, Safe Orthopaedics is getting ready for its commercial launch.
« Obtaining the FDA approval for the 2nd Generation SteriSpineTMPS in the United States is an important milestone in entering our second decade, as we observe a real adoption of ready-to-use technologies on a global scale and growing competition. Thanks to the feedback from our European users, we have designed this thinner, more rigid and totally radio-lucent evolution for an easier minimally invasive surgery, now meeting the expectations of American surgeons.», comments Pierre Dumouchel, Safe Orthopaedics Chief Executive Officer. « Following our first experience in the United States, we are very attentive to developments happening in the world's leading market, and are organizing ourselves to make the SteriSpineTMPS second generation available to American surgeons. The acceleration of outpatient surgeries, in dedicated centers called Ambulatory Surgery Centers (ASC), represents a new business opportunity for Safe Orthopedics. Combined with a very short production cycle made possible by the acquisition of LCI Medical, in 2021 we will launch a new distribution method, totally digital and perfectly fitted to the ASC. "