We’re excited to announce Kleiner Device Labs, an Equifund-listed medtech company with patented technologies to fight backpain, has officially received U.S. Food and Drug Administration 510(k) market clearance for its KG™2 Surge™ flow-thru interbody system.
The KG2 Surge system is the company’s next-generation device for spinal fusion surgery. It improves upon the already-in-market KG1 system and has the potential to enhance patient outcomes while also reducing surgical costs.
Several key advantages of KG2 include:
- It maximizes the amount of bone graft material that can get delivered…
- It better distributes the graft material into the disc space…
- And it streamlines the implant delivery, positioning, and grafting process.
Jeff Kleiner, MD, founder and CEO of Kleiner Device Labs stated…
“Getting adequate graft fill volume and distribution of graft within the intervertebral disc space is one of the most vexing challenges in spinal fusion procedures, which led us to develop the unique flow-thru technology in our KG series products. The new KG2 Surge system integrates graft delivery with the interbody device delivery. It allows the surgeon to first distract the disc space by inserting the implant, and then pack the entire disc space through the KG2 Surge implant.”
According to Kleiner, the KG2 system requires fewer instrument passes and decreases the potential trauma to nerve and surrounding tissue. It’s expected KG2 will also reduce the need for costly fusion repair surgeries by over 17%.
FDA clearance marks the culmination of years development and testing. It is a major milestone and step forward for Kleiner Device Labs.
Management has already reached agreements with a select group of surgeons to launch the product and will be building inventory for its full commercial launch.
For more information on Kleiner Device Labs, and how to invest in the company, please visit the company’s offering page.
A full version of Kleiner’s press release can be viewed here.
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