Kleiner Device Labs

Kleiner Device Labs, headquartered in Incline Village, Nevada, is a medical device company focused on the spinal surgery market. It was founded in 2013 by Dr. Jeff Kleiner, a spine surgeon with over 25 years of experience. Dr. Kleiner's frustration with the limitations of existing surgical instruments and a desire to improve patient outcomes led him to establish the company to develop and commercialize a new suite of technologies for spinal fusion procedures.

The company's primary business involves designing, manufacturing, and selling specialized spinal implants and instruments directly to hospitals and ambulatory surgery centers (ASCs). The business model targets the multi-billion dollar spinal fusion market by offering tools that aim to make surgeries safer, faster, and more effective. Kleiner Device Labs generates revenue through the sale of its single-use, sterile-packaged surgical systems. The company has engaged in multiple funding rounds, including a Regulation Crowdfunding offering, to finance product development, marketing, and commercial rollout.

A key product is the KG2 Surge® flow-thru interbody system, which received FDA 510(k) clearance in September 2021. This system is designed for transforaminal and posterior lumbar interbody fusion (TLIF/PLIF) procedures. Its distinctive feature is the integration of the implant delivery with the bone graft delivery process. The KG2 system consists of a 3D-printed titanium implant with a unique I-beam architecture and an open design, pre-attached to a rectangular, cannulated inserter. This design allows surgeons to first position the implant to distract the disc space and then deliver a large volume of bone graft material directly through the inserter and the implant, ensuring a thorough fill of the disc space. This single-pass process streamlines the procedure, reduces the number of instrument passes, and minimizes nerve tissue contusion risk. The system comes pre-assembled and sterilized in a single-patient-use tray, which simplifies preparation for operating room staff and is ideal for both hospitals and ASCs.

Keywords: spinal fusion, medical device, surgical instruments, interbody fusion cage, bone graft delivery, lumbar surgery, medtech, Jeff Kleiner, KG2 Surge, TLIF, PLIF, minimally invasive spine surgery, 3D-printed implant, orthopedic implants, neurosurgery devices, spine technology, FDA 510(k), surgical outcomes, single-use medical devices, operating room efficiency