The US Food and Drug Administration (FDA) has given 510(k) clearance to the PRO-LINK titanium stand-alone cervical spacer system (Life Spine) for spinal fusions.
PRO-LINK feature’s Life Spine’s OSSEO-LOC surface treatment, and has experienced great success since inception, a press release states. The company states that it is pleased to announce the 510(k) clearance, as it adds additional footprint sizes that enhance the ability to treat a wider variety of patient anatomies.
“The expanded footprint offering of PRO-LINK Titanium helps me address a larger patient population by accommodating smaller and female patient anatomy,” says Randall Dryer (Central Texas Spine Institute, Austin, USA).
“We have experienced great success and recorded explosive growth rates with the system since inception. I’m excited to see further expansion of the cervical portfolio, especially the enhanced footprints with the PRO-LINK Titanium system,” says Mariusz Knap, vice president of market and business development (Life Spine).
The FDA granted 510(k) marketing clearance to the company’s PRO-LINK Titanium stand-alone cervical spacer system in September 2016, with the device’s use in initial clinical cases being announced later that same autumn.
“OSSEO-LOC is a proprietary surface treatment for titanium with 500-600 microns of porosity, which helps create an environment for potential bone growth,” explains Rich Mueller, chief operating officer (Life Spine), speaking in 2016 after the product’s market clearance was granted. “Due to the structural integrity of titanium, we were also able to include lateral graft windows for maximum bone graft volume and visibility.”