Nextremity Solutions, Inc. Receives FDA 510(k) Clearance For Lapidus Procedure System

Friday, May 4, 2018 General News
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WARSAW, Ind., May 4, 2018 /PRNewswire-iReach/ -- 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 received 510(k) clearance by the Food & Drug Administration to market its upcoming InCoreTM
Lapidus System.

"We're excited about the 510(k) clearance of our InCore Lapidus System.  The team has worked hard to deliver a precision-guided, stable, intra-osseous solution for fusion of the first tarsometatarsal joint.  Our InCore Lapidus System aides the surgeon in correction and stabilization of the multi-planar deformity while providing distraction and visibility to allow for the surgeons preferred joint preparation.  The team was also focused on repeatable, procedural efficiency and controlled compression of the final construct.  We look forward to educating surgeons on this new technology," said Ryan Schlotterback, Chief Commercial Officer of Nextremity Solutions.

Rod K. Mayer, President of Nextremity Solutions said, "I am very thankful for the collective efforts of our surgeon and product development team members that accomplished this milestone. We are confident that this innovative solution will become a leading technology that advances patient care."

The Nextremity Solutions InCore Lapidus System is indicated as a three-part construct intended for internal fixation for First Metatarsocuneiform Arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion). 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 ReadyŪ 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.

Media Contact: Dave Temple, Nextremity Solutions, Inc., 574-635-3022, dave.temple@nextremity.com

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SOURCE Nextremity Solutions, Inc.



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