Osseus Fusion Systems has been granted what it describes as the first ever FDA standalone indication for an integrated ALIF interbody utilising alternative fixation without the need for supplemental fixation.
The medical device company introduced the Osseus Pisces-SA standalone Anterior Lumbar Interbody Fusion (ALIF) system last year, with the FDA granting 510 (k) clearance in May.
This unique indication has been in Osseus’ sights since early 2022, when the company’s R&D Engineering Manager John Bohenick told TCT the company was hoping to make a ‘splash on the market’ with the FDA’s approval of its latest 3D printed medical device.
Osseus has developed the Pisces-SA ALIF device to give surgeons the option between screws and anchors when fixating the device inside a patient to stabilise their spinal segment. Until now, no integrated ALIF interbody that uses alternative fixation has been approved by the FDA as a standalone device, which has meant supplemental fixation has had to be implanted in a secondary procedure to work in conjunction with the integrated ALIF device.
In order to receive such approval from the FDA, Osseus performed and presented the FDA with ‘extensive biomechanical testing’ to demonstrate that its Pisces-SA interbodies with alternative anchor fixation and stabilise spinal segments equally to market standard ALIF interbodies with traditional screw fixation.
“In an industry with many similar devices, Osseus uses cutting-edge technology and improved design techniques to innovate its implants,” commented Kelly Shelton, President of Osseus. “As a result, we are excited to announce the FDA has approved our latest portfolio addition, the Pisces-SA, as a true standalone ALIF device whether using traditional or alternative fixation and additional procedures, gives surgeons new flexibility – while preserving the indication as ‘on label’ use. We are thrilled to offer this one-of-a-kind product to the market and are confident that giving surgeons this new option will lead to improved patient outcomes.”
“The ability to use this product in a truly standalone fashion, without supplemental fixation, is a game-changer for my practice and patients,” offered Dr Thomas Jones, III, an orthopaedic surgeon with The Spine Institute of Southeast Texas. “I now have the option to use those products in the safest and most efficient manner by limiting the procedure to an anterior-only approach. This allows for greatly reduced procedure time which is something I am constantly searching for.”
