FDA clears SpineEx’s Sagittae spinal fusion device

SpineEX recently received FDA 510(k) clearance for its Sagittae lateral lumbar interbody fusion (LLIF) device.

Sagittae is a personalized, adjustable and expandable LLIF device that is designed to minimize impaction while maximizing indirect decompression. It also offers a large graft space that is useful for lumbar fusion procedures. The Sagittae is designed for up to 8mm of continuous in situ expansion with up to 30 degrees of continuous in situ lordotic adjustment. Its single graft chamber is able to be filled with bone graft material after insertion and adjustment.

LLIF procedures use minimally invasive techniques to work on the spine from the side of a patient, which means there is a larger implant footprint without messing with lower back muscles.

“Sagittae is a personalized, expandable spinal implant with an intra-operative adjustability ability for any height and any lordotic angle needed in a patient’s specific anatomy. This new lateral cage minimizes the need to forcefully impact the cage into the disc space,” Roy Chin, executive chairman and CEO of SpineEX, said in a press release.

SpineEX’s Sagittae personalizes the LLIF device for each patient’s needs for restorative independent high and lordotic angle to enable a proper anatomical fit. The device gives surgeons a variety of options to address sagittal balance while eliminating implant inventory that is typically needed for procedures.

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