Osseus obtains FDA 510(k) clearance of Pisces-SA spinal implant
Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System. The Pisces-SA interbody can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility.
Biomechanical testing proved that the Pisces-SA anchors provide better expulsion resistance and perform comparably with traditional screw-based standalone ALIF constructs in stabilizing injured spinal segments. The Pisces-SA is the first of its kind to provide this level of expulsion resistance and segmental stabilization using an alternative fixation method.
The Pisces-SA anchors allow for a streamlined, direct anterior approach which facilitates minimal access and improved operational efficiency. Dr. Michael Hisey, an orthopedic surgeon with Texas Back Institute in Plano, TX, describes the system’s versatility, “I’ve used screws […], and I’ve used the blade-type constructs, but I’ve never used a device where you could make that choice intraoperatively. I really like that ability to make my decision at the time.”
This innovative platform integrates a highly porous 3D printed interbody with anatomical morphology designed for full osseointegration with streamlined instrumentation to facilitate a minimally invasive approach. Osseus believes the Pisces-SA sets the new standard for Standalone ALIF devices.
“Receiving FDA approval for the Pisces™-SA is the culmination of relentless work from our R&D department and surgeon design team. We feel this product launch will solidify Osseus as one of the leading innovators in the spine industry,” says Rob Pace, Founder and CEO of Osseus. “Since our inception, we have pushed the envelope creating minimally invasive products to help simplify and streamline procedures. This product hits that mark, and we are excited to introduce it to the market. This is a special day for our company and for the team of surgeons who have provided extensive input on this groundbreaking product.”
