ExtremitiesRegulatory

Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Lesser Tarsometatarsal (TMT) Joint Arthrodesis System

WARSAW, IND. (PRWEB) JANUARY 06, 2020

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity 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 InCore® TMT System.

“Preparing the lesser tarsometatarsal joint for fusion and placing fixation poses difficulties due to the challenging bony anatomy and soft tissue. The InCore TMT is an exciting addition to the successful InCore Lapidus system, addressing the need to provide the necessary distraction for visualization and joint preparation, in addition to controlled compression at the fusion site. This new system applies all the advantages of InCore Lapidus including the solid intraosseous fixation construct aimed to minimize hardware prominence. We look forward to seeing this become another important solution to this common but challenging procedure,” said Greg Denham, Director of Product Development, Early Intervention for Nextremity Solutions.

Building on the success of the three-part construct design of the InCore Lapidus System for first TMT fusion, the InCore TMT System focuses on second and third TMT fusion, more commonly known as a Lisfranc joint fusion. Lisfranc fusions are intended to help provide stability to the midfoot and restore the anatomical arch of the patient’s foot.

Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions said, “The team has done an excellent job of expanding our InCore technology platform and building on the clinical success of InCore Lapidus. We’re excited about introducing InCore TMT to the market, as well as future variations in the pipeline. The InCore TMT product launch will be one of many to come in 2020. We remain focused on continuing to work with our surgeon and industry partners to bring exciting, Revenue Ready® solutions to the market.”

The Nextremity Solutions InCore TMT System is indicated as a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/3rd Tarsometatarsal Fusion).

About Nextremity Solutions, Inc.

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

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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