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Classified in: Health
Subject: FDA

Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Stratumtm Foot Plating System


WARSAW, Ind., April 3, 2019 /PRNewswire-PRWeb/ -- Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in "The Orthopedic Capital of the World," Warsaw, Ind., today announced it has recently received 510(k) clearance by the Food & Drug Administration to market its upcoming Stratum Foot Plating System.

Ryan Schlotterback, Chief Technology Officer of Nextremity Solutions said, "This is an important milestone for our company and the largest system we've brought to market to date. The team has spent a tremendous amount of effort with our surgeons to develop a comprehensive foot plating system that includes several innovative components; all working together to make foot plating simpler and more reproducible. The system includes implants with specific features that, along with a bicortical compression system, eliminate the decade's old compression slots. We believe these features, along with a host of others, create efficiency and stability not seen before in foot plating. The team has achieved all of this with an efficient and fully disposable instrument set. The Stratum Foot Plating system will be an important platform as we continue to develop our product portfolio."

"We are very excited about initial responses we are receiving from surgeons. Specifically, surgeons are intrigued by the unique tines that give the surgeon the ability to manipulate small bones and free up hands during the case. They also see tremendous value in the innovative external compression ramp that helps generate bicortical, linear compression. The unique features of the comprehensive Stratum Foot Plating System truly make it the next generation in plating," said Mike Coon, Chief Commercial Integration Officer for Nextremity Solutions.

The Nextremity Solutions Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. An application for a CE mark is pending.

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready® products for various musculoskeletal applications and for the benefit of our industry partners. The Company's procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit https://www.nextremitysolutions.com/ or call Dave Temple, Executive Director of Marketing & Communications at 574-635-3022.

 

SOURCE Nextremity Solutions, Inc.


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News published on 3 april 2019 at 11:00 and distributed by: