This article is more than 5 years old. Information may no longer be current.
TranS1 Inc. announces 510(k) FDA clearance for minimally invasive lumbar fusion system
Click Here to Manage Email Alerts
TranS1 Inc., a pioneer in minimally invasive approaches to lumbar spine surgery, today announced the 510(k) FDA clearance of the AxiaLIF 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion.
The AxiaLIF 1L+ system represents the next generation of the original AxiaLIF 1L system first launched in 2005 that has a clinical history of over 10,000 implants, according to a company press release. TranS1 will commence a limited market release immediately with the new implant and instrumentation and anticipates full commercial release in the second half of 2011.
"Our new AxiaLIF 1L+ system further demonstrates TranS1's commitment to continuously advance our proprietary AxiaLIF core technology. The 1L+ system builds upon our successful 2L+ system launched last year," stated Ken Reali, TranS1's president and CEO. "The modular approach of the 1L+, coupled with the tapered tip design, allows for more precise distraction capabilities and improvement in pull out strength. Further, through our minimally invasive pre-sacral access, the 1L+ implant provides a biomechanically stable implant at the base of the spine."