, /PRNewswire/ -- Phygen, LLC, a company focused on the development of devices used in the stabilization and repair of spinal disease and trauma, today announced that it has received a Notice of Allowance for its latest pedicle screw assembly utilizing the AutoLok technology. The unique design and its inherent resistance to back-out will provide a decided advantage to the product line as the company continues to implement physician driven innovations in spinal health.
"We are pleased to receive this Notice of Allowance and plan to move forward rapidly on the regulatory and operational fronts with the Leucadia AutoLok said Phygen CEO . "The clear advantages of this revolutionary feature will provide our clinical users with innovation developed through our clinical advisory members. We plan to quickly ramp up our regulatory and manufacturing efforts to get AutoLok technology back into the hands of clinicians as soon as possible. Our clinical advisory board considers this the most significant innovation in pedicle screws since pedicle screws became the gold standard in fusion."
AutoLok was initially introduced in 2011, and over 400 levels were implanted in spinal fusion cases, with no instances of backout and no revisions or field complaints of any kind. AutoLok was taken off the market after Phygen's asset sale in 2012, and Phygen has now re-acquired full ownership of the technology.
Spinal disease is the leading cause of lost productivity and surgical intervention in with an annual cost of more than .
Phygen LLC is a medical device company focused on the development of surgeon-designed orthopedic spinal implants and instrumentation to address the stabilization and repair of spinal trauma and disease. Laguna, Lucadia, , , and Cabo all represent Phygen products designed by spine surgeons for spine surgeons. For more information, please visit www.Phygenspine.com.
, CEO | Tel: (949) 752-7885 x105 - or