Medical device company Osseus has announced the FDA 510(k) clearance and launch of its Pisces-SA standalone Anterior Lumbar Interbody Fusion (ALIF) system.

The Pisces-SA interbody can be used with both bone screws and alternative fixation bone anchors to allow for increased intraoperative flexibility. It is the latest Osseus device to lean on 3D printing, with the technology being deployed to facilitate a highly porous interbody to support full osseointegration. Osseus has previously used 3D printing in the development of its Aries interbody fusion devices, which also received FDA clearance.

Becoming the tenth spinal fusion and fixation product within Osseus’ product line to receive clearance by the FDA, the Pisces-SA has been proven to provide ‘better expulsion resistance than the competition and to perform comparably with traditional screw-based standalone ALIF constructs in stabilising injured spinal segments. Osseus also believes it to be the first product of its kind to provide this level of expulsion resistance and segmental stabilisation using an alternative fixation method.

This alternative fixation method allows for a more streamlined approach with minimal access and improved operational efficiency. Dr. Michael Hissey, an orthopaedic surgeon with Texas Back Institute in Plano, TX, has been among the early users of the Pisces-SA device.

“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,” Dr. Hissey said. “I really like that ability to make my decision at the time.”

Osseus believes its Pisces-SA ‘sets the new standard’ for Standalone ALIF products. The device is available at a range of heights between 9-19mm, in footprints between 23x29 mm and 23 x 39 mm, and has a 3D printed mesh structure which boasts 80% porosity and provides load bearing support.

“Receiving FDA approval for the Pisces-SA is the culmination of relentless work from our R&D department and surgeon design team,” commented Rob Pace, founder and CEO of Osseus. “We feel this product launch will solidify Osseus as one of the leading innovators in the spine industry. 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 ground-breaking product.”

Osseus discussed the Pisces-SA prior to this FDA clearance in a recent issue of TCT Magazine, while R&D/Engineering Manager John Bohenick also joined the latest Additive Insight Innovators on Innovators episode to discuss the use of 3D printing in the medical device market.

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