Aesculap Implant Systems out of Center Valley, Pennsylvania has received 510(k) clearance for the firm’s A-FIX stand-alone spinal fusion device. The system is designed to be implanted using the anterior approach.
Some details from the product use instructions:
As an intervertebral body fusion device designed for use with autograft, the A-FIX® Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s).
The A-FIX® spacers are made of PEEK-OPTIMA®. They contain marker pins made of tantalum to ensure radiological visibility for inspecting the implant position. The A-FIX® screws are made of titanium alloy (Ti6Al4V).