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Product OVerview
THE KG™2 SURGE™ SOLUTION
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.
In-Situ Graft Delivery
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.
KG™2 Surge™ Architecture
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.
KG™2 Surge™ provides a comprehensive, single patient use system for TLIF and PLIF procedures
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.
Touch Free Technology
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.
Innovative Design
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.
EFFECTIVE GRAFTING CONDUIT
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.
Cutting Time, Effort and Revision Risk
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.
Industry Accolades
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."
"I have had the opportunity to use the KG 2 system and have found it to be extremely simple to use, not just from a surgeon's perspective but for everyone in the OR. It allows the benefits of a single use tray and provides my patients and me superior safety and an unparalleled ability to maximally bone graft the disc space with a single instrument pass."
GRAFT FLOW STUDY
ROUND & END DISPENSING
RECTANGULAR & BIFURCATED
SCORING KEY
- The cannula can be filled entirely with graft material and pushed through with minimal effort.
- The cannula can be filled 50% with material pushed through easily.
- Strict adherence to the instructions for use (IFU) is necessary for this material to be used. The cannula funnel should serve as a reservoir with 1 to 2 mL of material being applied and the plunger pushed all the way to the bottom to expel the graft material.
- The graft material must be mixed with more flowable diluents and strict adherence to the IFU is necessary. The cannula funnel should serve as a reservoir with 1 to 2 mL of material being applied and the plunger pushed all the way to the bottom to expel the graft material.
* 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”.
FLOW CHARACTERISTICS OF BONE GRAFT TESTED WITH KG™2
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.