Osseus was granted what is reportedly the first-ever FDA standalone indication for an integrated Anterior Lumbar Interbody Fusion (ALIF) device utilizing alternative fixation without the need for supplemental fixation.
The primary goals of integrated fixation in ALIF interbodies are to prevent interbody expulsion and stabilize the spinal segment. Traditionally, screws have been used as the integrated fixation method for standalone devices. However, inserting these screws can be challenging due to extreme insertion angles and anatomical impediments. There are also alternative fixation methods such as anchors, blades, etc. that can be implanted through specialized inserters which allow for a minimally invasive, direct anterior approach with no need for additional instrumentation to overcome angulation challenges.
Although these alternative fixation methods are quicker and easier to insert, until now with the Pisces-SA, no integrated ALIF interbody utilizing alternative fixation has been cleared by FDA as a standalone device. This means that supplemental fixation (e.g., facet screws or posterior fixation) must be implanted in a secondary procedure to work in conjunction with the integrated ALIF device to adequately stabilize the spinal segment.
Kelly Shelton, President of Osseus, said, “We are excited to announce the FDA has approved our latest portfolio addition, the Pisces-SA, as a true stand-alone ALIF device whether using traditional or alternative fixation. Not requiring supplemental fixation and additional procedures, gives surgeons new flexibility – while preserving the indication as ‘on label’ use.”
Osseus was granted what is reportedly the first-ever FDA standalone indication for an integrated Anterior Lumbar Interbody Fusion (ALIF) device utilizing alternative fixation without the need for supplemental fixation.
The primary goals of integrated fixation in ALIF interbodies are to prevent interbody expulsion and stabilize the spinal...
Osseus was granted what is reportedly the first-ever FDA standalone indication for an integrated Anterior Lumbar Interbody Fusion (ALIF) device utilizing alternative fixation without the need for supplemental fixation.
The primary goals of integrated fixation in ALIF interbodies are to prevent interbody expulsion and stabilize the spinal segment. Traditionally, screws have been used as the integrated fixation method for standalone devices. However, inserting these screws can be challenging due to extreme insertion angles and anatomical impediments. There are also alternative fixation methods such as anchors, blades, etc. that can be implanted through specialized inserters which allow for a minimally invasive, direct anterior approach with no need for additional instrumentation to overcome angulation challenges.
Although these alternative fixation methods are quicker and easier to insert, until now with the Pisces-SA, no integrated ALIF interbody utilizing alternative fixation has been cleared by FDA as a standalone device. This means that supplemental fixation (e.g., facet screws or posterior fixation) must be implanted in a secondary procedure to work in conjunction with the integrated ALIF device to adequately stabilize the spinal segment.
Kelly Shelton, President of Osseus, said, “We are excited to announce the FDA has approved our latest portfolio addition, the Pisces-SA, as a true stand-alone ALIF device whether using traditional or alternative fixation. Not requiring supplemental fixation and additional procedures, gives surgeons new flexibility – while preserving the indication as ‘on label’ use.”
Copy to clipboard 
