ExtremitiesRegulatory

Gramercy Extremity Orthopedics® Receives FDA 510(k) Clearance for GEO FirstFuse MTPJ Fusion Plating System

RICHARDSON, TEXAS, UNITED STATES, March 30, 2020 /EINPresswire.com/ — Gramercy Extremity Orthopedics® (GEO) today announced it has received the U.S. Food and Drug Administration’s (FDA) 510(k) clearance for the GEO FirstFuse MTPJ Fusion Plating System, which is an indication-specific plating system used to achieve arthrodesis of the foot’s first metatarsophalangeal joint. Like all other implant solutions in the GEO portfolio, the plates and screws of this new plating system are individually sterile-packed, complimented by single-use, disposable instrument kits. This addition to the company’s product line – its first plating system – marks a major milestone for Gramercy Extremity Orthopedics.

The GEO FirstFuse System offers an array of plate size options (small, medium, and large/revision), including dorsiflexion (0 or 5 degree bends) and abduction (also 0 or 5 degree choices) angles. All plates will accommodate an assortment of cortical locking, as well as cortical and cancellous non-locking, screws to ensure a strong, stable construct.

“FDA’s clearance for GEO’s FirstFuse plating system allows us to better leverage our existing technology,” says Scott Day, Chief Commercial Officer of Gramercy Extremity Orthopedics. “For several months, health systems throughout the United States have begun realizing the efficiencies of the GEO model. This latest addition dramatically increases the number of procedures and indications covered by the GEO CART®. Each product portfolio expansion allows facilities to more frequently utilize the RFID technology-driven electronic charge sheets, automatic restock feature, and a safe, sterile delivery system, which greatly reduces the dependency on outside personnel and product support during the procedure.”

GEO expects to make the FirstFuse MTPJ System commercially available in limited release by the Summer of 2020.

*GRAMERCY EXTREMITY ORTHOPEDICS and GEO are proprietary trademarks of Gramercy Extremity Orthopedics, LLC. All rights reserved.

Scott Day
Gramercy Extremity Orthopedics
+1 855-436-2278
email us here

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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