KG ™ 2

Delivering Maximal Graft at Minimal Risk

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

THE PROBLEMS

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 involves a separate step with a round, end-dispensing device that applies a mantle of graft at the front of the disc space which needs to be further manipulated to make room for a fusion cage.

THE SOLUTION: KG 2

Introduction of the KG 2 implant restores anatomic disk height and allows near simultaneous application of bone graft and which enables maximal graft application. The exceptional design of the KG 2 implant allows it to serve as a conduit for bone graft insertion and is the first device of its kind to couple graft application with implant insertion. This process saves steps, reduces nerve manipulation and encompasses the implant and prepared disc space in bone graft.

Example with pig spine

Watch: KG 2 Deployment

Watch: KG 2 Full Overview

WHAT IS IT?

The KG 2 system provides the surgeon with a single use PLIF or TLIF sterile tray in parallel or lordotic implant configurations. After disc space preparation, it simplifies the open or MIS fusion procedure by combining steps, minimizes nerve manipulation by reducing the number of instrument passes and maximizes graft application.

KG 2 IMPLANT FEATURES

Optional coverplate to restrict graft migration. Internal ramps direct bidirectional flow of graft material into the prepared disc space The open architecture maximizes graft flow.

HOW DOES IT WORK?

Innovative Design

  • The KG 2 system 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 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 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 Both Effort and Cost

KG 2 requires fewer instrument passes decreases potential trauma to sensitive nerve and dural tissue. It reduces the learning curve for MIS surgical procedures, blood loss potential and infection risk. KG 2 is expected to diminish the need of 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.

3D PRINTED OSSEOINTEGRATIVE SURFACE

Diamond lattice structure: Pore size (600 μm), porosity (65%), and structure 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 Implant with 3D-printed surface topography

Watch: KG 2 Optional Coverplate

OPTIONAL COVERPLATE

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