Pressio Spine™ Receives FDA 510K Clearance for the CONTINUUM™ ACDF Nitinol Fixation System
Pressio Spine (Pressio, Inc.), is proud to announce the FDA approval (510K / K200301) of the CONTINUUM™ ACDF Nitinol Fixation System for single-level use in anterior cervical discectomy and fusion (ACDF) procedures from C3 to C7 in conjunction with a surgeon’s choice of interbody device.
The Pressio Spine CONTINUUM™ ACDF Nitinol Fixation System is comprised of compact, pre-sterilized, fully disposable kits, each containing a CONTINUUM™ Implant as well as ancillary instruments. The implants are made of biocompatible Nitinol which exhibits shape memory and superelastic properties designed to provide continuous compression of bone segments to maintain construct stability during the fusion cascade. Combined with the improved logistics and patient safety afforded by pre-sterilized kits, the Pressio Spine CONTINUUM™ ACDF Nitinol Fixation System represents the evolution of spinal fixation.