ZygoFix has obtained CE mark for its minimally invasive screwless spinal fusion system, called zLOCK, for the treatment of chronic back pain.
ZygoFix completed the certification process and received CE mark for its zLOCK spinal fusion system for lumbar spine after demonstrating its safety and efficacy in clinical studies. Together with this certification, ZygoFix also received ISO13485 certification.
The zLOCK system’s miniature 3D-printed implant aims to utilise the spine’s anatomy for spinal stability, rather than traditional external screw-based stabilisation. Its features combine rigid and bendable elements that enable the implant to withstand loads applied through the spine, while conforming to each patient’s anatomy during implantation. The procedure eliminates risks associated with improperly placed screws, is less invasive, simple to use, and suitable for outpatient implantation, say ZygoFix.
Ofer Levy, ZygoFix CEO, said: “Receiving CE Mark is a key event for the zLOCK system as a minimally invasive and safer solution for back pain sufferers. ZygoFix is opening a multi-centre pivotal study in the EU to collect further clinical data.”
The zLOCK system has been in clinical use for more than three years in Hungary and Israel.