Press Releases

February 03, 2021

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.

Safe Harbor Statement:
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

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