Spinal Elements Receives 510(k) Clearance for Interspinous Process Device

Spinal Elements has received 510(k) clearance from the U.S. Food and Drug Administration to market an interspinous process device.
 
Interspinous process devices are placed between the spinous processes of the spine and provide support and fixation while a spinal fusion forms. The devices can be less disruptive to the spine because minimal muscle and tissue retraction is required to surgically implant them. These characteristics have made the devices attractive in the ambulatory surgical center and outpatient spine markets.
 
Spinal Elements’ device includes enhancements that make the device more accommodating to patient anatomy while streamlining the surgical procedure. The surgeon will be able to intraoperatively choose the approach that best suits their needs and the needs of their patients. The device may be implanted with minimally-invasive surgical (MIS) techniques or conventional techniques and may be used in superspinous ligament sparing or sacrificing approaches. Whatever the use, the instruments have been optimized and balanced to provide for an accurate and reproducible procedure.
 
“This clearance is another indicator of our pursuit of solutions demanded by our surgeon customers. This device addresses part of our strategy to become the first choice of surgeons in both hospital and outpatient surgery settings,” said Todd Andres, CEO and co-founder of Spinal Elements.
 
The company plans to begin clinical procedures with the interspinous process devices later this year with an initial launch in early 2017.

Headquartered in Carlsbad, Calif., Spinal Elements develops spinal technologies for surgeons. The company is focused on the development and marketing of progressive spinal treatment options and markets a portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero Allograft, the net proceeds from which are donated to charities benefitting children with life-threatening medical conditions.