Kleiner Device Labs announced that its new KG™2 Surge™ flow-thru interbody system was used in its first surgical procedure. Utilizing the new device, bone graft delivered through the KG 2 conduit was more than three times the volume of the void of the collapsed disk space.
KG2 Surge was granted FDA 510(k) marketing clearance in September 2021.
KG2 combines steps to streamline the implant introduction, positioning and grafting processes in lumbar spinal fusion procedures, and comes as a complete system with the selected size implant pre-attached, in a sterile tear-open pack.
The system is a single-patient-use bone graft delivery tool coupled with a 3D-printed titanium I-Beam fusion implant. The implant has no lateral walls and serves as a conduit for unimpeded flow of a broad spectrum of bone graft materials through the pre-attached, rectangular insertion tool. The rectangular cannula maximizes the cross-sectional area available for graft material flow and eliminates the challenge of trying to apply bone graft after cage insertion.
Since the system comes pre-assembled and sterilized in a single use tray, there is minimal scrub tech training and no implant tray re-processing/sterilization -- suitable for an ASC or hospital. Also, the implant is directly inserted—it is not touched or pre-packed. The KG2 system allows for a single insertion process to take the place of the multi-step, multi-instrument pass practice that is typical of current spinal fusion procedures. The surgical procedure with KG2 Surge spares contusion of delicate nerve tissue and reduces the risk of surgical site infection. Because the system comes pre-sterilized and pre-assembled, it also eliminates the back table "fiddle factor."
Source: Kleiner Device Labs