KG™2 Surge™ Flow-Thru Interbody System

Coming Soon

The KG 2 Solid State Fusion Cage simplifies and standardizes bone graft delivery method
and reduces the potential for operative complications in MIS Fusion Surgery.

THE KG2 DEVICE DOES NOT HAVE 510K CLEARANCE AT THIS TIME

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Watch: KG 2 Surge Deployment

The KG 2 Surge Solution

The new KG 2 Surge integrates graft delivery with the interbody device. It allows the surgeon to first distract the disc space by inserting the implant, and then pack the entire disc space uniformly through the KG 2 Surge, 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.

Example with pig spine

Shortcomings of Current Instrumentation & Process

Current surgical procedure to deliver bone graft is spread out over multiple surgical steps. Additional surgical steps increase operative time, surgical risk and surgeon fatigue. Graft delivery typically requires a separate step with a traditional round end-dispensing device that applies a mantle of graft material only to the front of the disc space, poorly filling the void and often requiring additional graft manipulation to allow proper positioning of the implant.

Watch: KG 2 Surge Flow-Thru Interbody Implant Full Overview

KG 2 Surge provides a comprehensive, single patient use system for TLIF and PLIF procedures

The KG 2 Surge 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 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.

KG 2 Surge Architecture

Kleiner Device Labs 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 disk 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 tactics into a single insertion step. In addition to simplifying the procedure, it reduces the number of instrument passes and reduces the risk of nerve irritation.

The KG 2 Surge features diamond lattice structure with pore size (600 μm) and porosity (65%) to facilitate bone ingrowth*

* “Effect of pore size on bone ingrowth into porous titanium implants fabricated by additive manufacturing: An in vivo experiment”, Taniguchi et. al.

KG 2 Surge Flow-Thru Interbody Implant with 3D-printed surface topography

Innovative Design

  • The KG 2 Surge Flow-Thru Interbody Implant combines implant and graft delivery in a single step. The novel, nested rectangular cannula insertion system securely attaches the implact until it is time for its release. The I-Beam contruction 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 easier passage of bone graft unavailable other implants.
  • Osseointegrative 3D surface

The large rectangular opening of the KG 2 Surge Flow-Thru Interbody Implant is 400% larger than the standard post-packing 4mm cannulas. This difference allows the surgeon a proportionally large number of graft options for surgical treatment unavailable to other implants.

Cutting Time, Effort and Revision Risk

The KG 2 flo-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 commonly implicated in opiate abuse.*

* Kleiner JB, et al. Evaluation of a novel tool for bone graft delivery in minimally invasive transforaminal lumbar interbody fusion. Medical Devices: Evidence and Research. 2016;(9) 105-113.

* Nandyala, SV, et. al. Prospective, randomized, controlled trial of silicate-substituted calcium phosphate versus rhBMP-2 in a minimally invasive transforaminal lumbar interbody fusion. Spine. 2014;39(3):185-191.

* Wu RH, et. al. Minimal access versus open transforminal lumbar interbody fusion: meta-analysis of fusion rtes. Spine. 2010;35(26):2273-2281.

Watch: KG™2 Surge™ Flo-Thru Interbody Implant Optional Coverplate

OPTIONAL COVERPLATE

  • Prevents flowable graft material from exiting the disc space through the KG™2 Surge™ Flo-Thru Interbody Implant
  • 3D printed Ti implant which is contained in the KG™2 Surge™ Flo-Thru Interbody Implant tray. It is inserted and deployed per surgeon preference.