Kleiner Labs Interbody Device Cleared by FDA

The FDA has 510(k) cleared Kleiner Device Labs’ KG2 Surge flow-thru interbody system.

Addressing “Vexing” Challenge

In a September 22, 2021, press release, company founder and CEO Jeff Kleiner, M.D., said getting adequate graft and fill volume and distribution of graft within the intervertebral disc space, “is one of the most vexing challenges in spinal fusion procedures.”

The company said the system “maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning and grafting process for TLIF and PLIF spinal fusion procedures.”

According to the FDA clearance documents, the KG2 is a cage intended for “lumbar intervertebral fusion (PLIF/TLIF approach). The design contains both solid and porous structures formed as a diamond mesh, and it contains a bone grafting hole.”

The device is 3-D printed titanium and features a diamond lattice porous structure to facilitate bone ingrowth and may be used with cover plate.

The sterile implant comes pre-assembled on the inserter and includes pre-packaged sterile, single-use instrumentation for primary insertion, graft passing, and cover plate insertion. A reusable set of instruments is included for disc preparation, trial sizing, and repositioning/removal.

“The surgeon opens our tray with a ready-to-use system in their hands. The learning curve is low for operating room staff, and the KG2 Surge system works in both MIS [minimally invasive spine] and open approaches. The associated reusable instrument package allows for immediate revision at every step, should the surgeon desire implant repositioning or removal,” stated the company press release.

The devices will initially be available in footprints of 9x24mm, 11x28mm and 11x32mm, with heights of 7 to 14mm, and lordosis of 0 and 6 degrees.

Indications

According to the FDA documents, the implant is indicated for “transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels.

“The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level.”

It took the FDA about four months to clear the device after determining the KG2 is substantially equivalent to predicates from Osseus Fusion Systems, Stryker Corporation (K2M) and NuVasive, Inc.

Here’s a short video of how the system works.