RegulatorySpine

Safe Orthopaedics receives 510k approval from the FDA for the sale of its 2nd Generation of SteriSpineTM PS in the United States

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. “

Finally, Safe Orthopedics, which already holds around a hundred patents, is also announcing today the acquisition of the Japanese patent for its Oak screw, an implant from the SteriSpineTMPS range offering an unprecedented minimally invasive surgical technique for treating high-energy fractures.

About Safe Orthopaedics 
Founded in 2010, Safe Orthopaedics is a French medical technology company, a pioneer of the design and marketing of innovative ready-to-use technologies (single-use implants and instruments) for spinal diseases, delivering the safest treatment of spinal fractures. The technologies include sterile implants and ready-to-use instruments available to the surgeon at any time and anywhere, enabling minimally invasive approaches, reducing the risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpineTM Kits are CE marked, FDA and CFDA approved.
Safe Orthopaedics, has its headquarters close to Paris (95610 Eragny-Sur-Oise – France) and has created sales subsidiaries in the UK, Germany and in the US, and since July 2020 has industrial subsidiaries in France and Tunisia.
Safe Orthopaedics is employing around 150 employes and delivers its products worldwide.


For more information : www.SafeOrthopaedics.com   


Contacts 

Safe Orthopaedics
François-Henri Reynaud                                                     
Chief Financial Officer                       
Tél. : +33 (0)1 34 21 50 00                                              
investors@safeorthopaedics.com

Press relations
Ulysse Communication
Bruno Arabian / +33 (0)6 87 88 47 26 / barabian@ulysse-communication.com
Nicolas Daniels / +33 (0)6 63 66 59 22 / ndaniels@ulysse-communication.com

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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