FDA clearance for joimax EndoLIF On-Cage: 3D printed fusion implant
July 31, 2015
German company Joimax, a developer of technologies and training methods for minimally invasive endoscopic spinal surgery, has announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage.
The EndoLIF On-Cage consists of titanium alloy produced with Electron Beam Melt (EBM) technology. The cage displays a porous surface with diamond cell structure, providing an optimal base for cell proliferation and bone growth. Two large openings, which may be filled with autogenous bone, support the creation of a straight column for fusion.
The EndoLIF implant allows surgeons to utilise an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion (TLIF), into the intervertebral disc, enabling endoscopic-assisted fusion.
Dr Ralf Wagner, from the LIGAMENTA Spine Center, Frankfurt and Dr Bernd Illerhaus, from ONZ, Datteln/Recklinghausen, two German spine specialists, have already performed more than 200 out of 600 EndoLIF procedures in Europe.
The EndoLIF On-Cage is designed to be used with supplemental posterior fixation, such as the joimax Percusys percutaneous pedicle screw-rod system. Cage implantation can be performed with a posterior or postero-lateral approach, either using an open or endoscopic-assisted method.
“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,” commented Wolfgang Ries, CEO and founder of Joimax. “Our next development will be an EndoLIF Cage on the basis of our iLESSYS Delta system for posterior lumbar inter-body fusion (PLIF).”
