On May 5, 2022, the FDA granted 510(k) clearance to Osseus Fusion System, LLC’s Pisces-SA Standalone ALIF Interbody System. It took the agency almost six months to clear the system. The Dallas-based company announced the clearance on May 9, 2022.
FDA Clears Osseus Standalone ALIF System
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The company says biomechanical testing proved that the system’s anchors provide “better expulsion resistance” than the competition and perform “comparably with traditional screw-based standalone ALIF constructs in stabilizing injured spinal segments.” The company claims the Pisces is the “first of its kind” to provide this level of expulsion resistance and segmental stabilization using an alternative fixation method.
The Pisces platform, according to the company, integrates a highly porous 3D printed interbody with anatomical morphology, “designed for full osseointegration with streamlined instrumentation to facilitate a minimally invasive approach.”
Michael Hisey, M.D., of the Texas Back Institute, says the Pisces anchors, “allow for a streamlined, direct anterior approach which facilitates minimal access and improved operational efficiency.” He added that he’s used screws and 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.”
FDA documents describe the system as an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices; intended for use in patients with degenerative disc disease at one or two contiguous levels of the lumbosacral spine (L2-S1).
When used with anchors or without screws, the devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).
The system’s spacers are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1).
Company Founder and CEO Rob Pace said he and his colleagues feel this product launch “will solidify Osseus as one of the leading innovators in the spine industry.”
Founded in Dallas in 2014, Osseus is privately held. The company’s product line includes ten spinal fusion and fixation systems including: the Black Diamond Open and Minimally Invasive Pedicle Screw Systems, White Pearl Anterior Cervical Plate, Gemini-C Cervical Interbody, Aries-TS, -TC, -L, and -A Lumbar Interbody Systems, Blue Topaz Sacroiliac Screw System, and now the Pisces-SA Standalone ALIF Interbody System.
The company says it is also developing the Black Diamond POCT Posterior Cervical Screw System which they expect to launch in late 2022.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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