Sam Brusco, Associate Editor05.06.24
ZygoFix has earned clearance from the U.S. Food and Drug Administration (FDA) for its zLOCK lumbar facet fixation system.
The zLOCK system uses the spine’s innate bone structure to securely lock its connecting joints. Different from traditional methods, the implant adapts to the joint’s anatomy during insertion. The procedure is minimally invasive and can be performed in outpatient and ASC (ambulatory surgical center) environments.
zLOCK also touts CE mark approval and six years of clinical use, which the company said has yielded long-term pain reduction and bone growth.
"Receiving FDA clearance for our zLOCK Lumbar Stabilization System is an exciting milestone, and I am very proud of the team that has worked hard to achieve this goal,” commented ZygoFix CEO Ofer Levy. “The system has garnered significant interest in the US market and this clearance paves the way for us to introduce our transformative solution to the US market, fostering collaboration with leading surgeons and enhancing patient care."
"Obtaining 510(k) clearance is a testament to ZygoFix's commitment to innovation and addressing the unmet needs of patients suffering from degenerative spinal conditions,” added ZygoFix chair Dr. Nicholas Pachuda. “We eagerly anticipate offering patients our minimally invasive, life-changing solution in the United States."
The zLOCK system uses the spine’s innate bone structure to securely lock its connecting joints. Different from traditional methods, the implant adapts to the joint’s anatomy during insertion. The procedure is minimally invasive and can be performed in outpatient and ASC (ambulatory surgical center) environments.
zLOCK also touts CE mark approval and six years of clinical use, which the company said has yielded long-term pain reduction and bone growth.
"Receiving FDA clearance for our zLOCK Lumbar Stabilization System is an exciting milestone, and I am very proud of the team that has worked hard to achieve this goal,” commented ZygoFix CEO Ofer Levy. “The system has garnered significant interest in the US market and this clearance paves the way for us to introduce our transformative solution to the US market, fostering collaboration with leading surgeons and enhancing patient care."
"Obtaining 510(k) clearance is a testament to ZygoFix's commitment to innovation and addressing the unmet needs of patients suffering from degenerative spinal conditions,” added ZygoFix chair Dr. Nicholas Pachuda. “We eagerly anticipate offering patients our minimally invasive, life-changing solution in the United States."