Safe Orthopaedics Gains FDA 510(k) for Next-Gen SteriSpine PS

By Julie A. Vetalice

Safe Orthopaedics Gains FDA 510(k) for Next-Gen SteriSpine PS

Safe Orthopaedics received FDA 510(k) clearance to market its second generation of the SteriSpine™ PS line of pedicle screws.

Developed in 2010, SteriSpine PS is reportedly the first pedicle screw technology combined with single use, sterile ready-to-use instrumentation. The next-gen version is significantly thinner, more rigid and still radiolucent. It has application in a wider number of spine pathologies.

The company delivered the updated system to Japan in 1Q20, and in 2Q, launched products in Europe and the Asia Pacific region. By the end of 2020, all French, English and German direct customers will have been converted.

Commercial launch preparations are underway. This marks Safe Orthopaedics' re-entry into the U.S., after regional operations were discontinued effective March 2016. In a letter to shareholders, Pierre Dumouchel, Chief Executive Officer, noted that  the company is developing a new partnership-based marketing strategy for regions such as Japan, the U.S. and China.

Furthermore, the company acquired a Japanese patent for its Oak screw, an implant from the SteriSpine PS range, offering a minimally invasive surgical technique for treating high-energy fractures. The Oak screw gained approval under the CE Mark in 2016.

"Obtaining the FDA approval for the 2nd Generation SteriSpine PS 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," said Dumouchel

"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 SteriSpine PS second generation available to American surgeons. The acceleration of outpatient surgeries, in dedicated centers called Ambulatory Surgery Centers (ASCs), represents a new business opportunity for Safe Orthopedics. Combined with a very short production cycle made possible by the acquisition of [manufacturing partner] LCI Medical, in 2021 we will launch a new distribution method, totally digital and perfectly fitted to the ASC. "

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory