3D Printing

joimax Receives FDA Approval for 3D Printed Spinal Implants

3D printing has already begun to disrupt the medical space, with low-cost prosthetics acting as a clear example of just how personal and affordable medical devices can be.  And, as stories are reported daily as to the ability to create patient-tailored implants with 3D printing, the FDA is continuing to approve these devices for implant.  The latest is a spinal implant from a German company called joimax, which just received 510(k) clearance from the US governmental body.

EndoLIF_On_Cage 3D printed implant

The Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage implant, is a titanium alloy implant manufactured with Electron Beam Melt (EBM) technology.  Due to its 3D printed nature, the implant can both be customized to the patient, by converting patient CT or MRI scans to 3D models, and it can be optimally designed.  The EndoLIF On-Cage has a porous, diamond-shaped structure in order for cells to grow throughout the structure and supporting bone growth.  With two large openings, the device can be filled with autogenous bone as a means of promoting the fusion of a straight spinal column.

Designed to be used with supplemental posterior devices, like the company’s own Percusys® product,the EndoLIF can be implanted through the muscle and into an intervertebral disc, so that doctors can fuse the device with an endoscope. According to the company, 600 EndoLIF procedures have already been performed throughout Europe. Wolfgang Ries, CEO and founder of joimax, says of the system, “With the EndoLIF program, joimax offers a complete endoscopic-assisted solution for spinal stabilization and fusion. In the future, we will be able to treat patients with even more gentle techniques. Our next development will be an EndoLIF Cage on the basis of our iLESSYS Delta system for posterior lumbar inter-body fusion (PLIF).”

Though it may be just one product from one company in the sector, the EndoLIF is part of a larger trend of implementing 3D printing in medical procedures.  This trend, which also includes such companies as Materialise and ConforMIS, will ultimately be one that becomes mainstream medical practice.