The new KG™2 Surge™ interbody implant system streamlines the implant, delivery, positioning and grafting processes. No other system integrates graft delivery with the interbody device in this way. It allows the surgeon to first distract the disc space by inserting the implant, and then fill the entire disc space uniformly through the KG™2 Surge™ implant via the attached cannulated inserter.
Fully packing the disc space while in the distracted and final position ensures graft/endplate contact and avoids graft dilution. The system’s large rectangular cannula allows simplified delivery of a wide range of allograft and autograft materials, including viscous and fibrous products.
KDL pioneered flow-thru I-beam architecture to eliminate the jamming, and poor graft distribution that plagues the use of traditional, round end-dispensing graft tools. The integrated ramp system directs bone graft into the prepared disc space resulting in an increase in graft volume and fill in order to promote biologic fusion. The KG™2 Surge™ flow-thru integrated implant and grafting system combines multiple surgical steps into a single insertion pass. In addition to simplifying the procedure, it reduces the number of instrument passes and reduces the risk of nerve irritation.
The KG™2 Surge™ system comes with the interbody device pre-assembled to the cannula in a single-use sterile tray. The surgeon opens the tray with a ready-to-use system in their hands. The learning curve is flat for operating room staff, and the KG™2 Surge™ system works equally well for both MIS or open techniques. An associated reusable instrument tray allows for implant revision at any step if implant repositioning or removal is necessary.
A preassembled, single use implant/insertion system eliminates the need to touch the implant. This has been shown to decrease the risk of bacterial contamination.
The large rectangular opening of the KG™2 Surge™ flow-thru implant is 400% larger than the standard post-packing 4mm cannula. This difference allows the surgeon a proportionately larger number of graft options for surgical treatment unavailable with other implants.
The KG™2 Surge™ flow-thru interbody system combines implant and graft delivery in a single step. The novel, nested rectangular cannula insertion system securely attaches the implant until it is time for its release. The I-beam construction of the KG™2 Surge™ flow-thru Interbody Implant maximizes the egress of graft material from the cage by eliminating its outer walls. The entrance portal of the implant has 400% more cross-sectional area than the conventional 4 mm post-packing, end-dispensing bone graft funnels. This difference allows for easier passage of bone graft unavailable with other implants. The titanium implant includes osseointegrative 3D printed surface technology.
The KG™2 Surge™ flow-thru implant requires fewer instrument passes, and decreases potential trauma to nerve and dural tissue. Along with flattening the learning curve for MIS surgical procedures, it decreases the potential for blood loss and infection risk. The KG™2 Surge™ implant is expected to diminish the need for fusion repair surgery by over 17%. Failed back surgery is believed to be a leading risk factor in developing opiate addiction.
Current surgical procedures require bone graft delivery spread out over multiple surgical steps. However, additional surgical steps increase operative time, surgical risk and surgeon fatigue.
The bifurcated dispensation, coupled with the unique flow-thru technology, uniformly distributes graft throughout the disc space and effectively self embeds the interbody implant in graft.
KDL has been recognized with the 2022 Medical Design Excellence Awards (Implant and Tissue-Replacement Products category) for its new KG™2 Surge™ flow-thru interbody system.
Medical Design Excellence Awards are geared toward “life-saving innovations and remarkable technological advancements."
"I was honored to perform the inaugural KG™2 Surge™ spinal fusion procedure. The system worked flawlessly, allowing precision placement of the interbody cage and fusion graft in a seamless sequential manner. The integrated fusion delivery system enabled a quick, maximum delivery of the graft material to the re-expanded disc space. The system is intuitive and reduces the number of steps usually needed to perform this procedure. There is minimal learning curve for the physician and our team."
Kleiner Device Labs has conducted hands-on testing of a wide range of commercially available bone graft materials to ascertain ease of flow characteristics through the KG™2 Surge™ device. These tests were not intended to recommend any material over another, nor to supersede indications for use.
These tests were performed with stock graft materials from their respective manufacturers. The testing results are shared to provide surgeons with flowability guidelines. Individual surgeons sometimes utilize their own blends of materials, which should be expected to affect flow performance. Surgeons may also expect to deliver more graft into the disk space with this system.
The best performance of the KG™2 Surge™ system will be achieved by following the IFU provided with the product packaging or on the Kleiner Device Labs website. These instructions include using the funnel as a reservoir and applying 1 to 2 mL of graft material per pass of the plunger.
* ICBG performs very differently depending upon how it is prepared. If put through 3 passes in a Stryker bone mill with medium or fine blades, ICBG will perform as a “1”. Two passes through the mill will result in “2” level performance. One pass will perform as a ”3” and no passes through a mill will perform as a “4”.
Studies have shown significant surgical site infection (SSI) risk associated with implant and instrument contamination due to handling and contact by surgical staff during procedures. (See study section below.) KDL has introduced "Touch Free" technology to eliminate the need for direct implant contact by surgeons and operating room staff.
Studies have also shown significant surgical site infection (SSI) risk associated with reprocessing reusable instrumentation. (See study section below.) The KG line of products are all single use instruments and implants to eliminate the cost and risk associated with reprocessing and re-sterilization.
Studies have shown a correlation between the volume of graft delivered and successful fusion rates. In-situ graft delivery allows for maximized volume of graft delivery to the intervertebral space.
Studies have shown a correlation between shortened operative times and a reduced risk of peripheral tissue damage in a range of lumbar interbody fusion techniques. A reduction in instrument passes is also believed to reduce the risk of peripheral tissue damage.
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