Gramercy Extremity Orthopedics Gains FDA Clearance for GEO FirstFuse MTPJ Fusion Plate

By Julie A. Vetalice

Gramercy Extremity Orthopedics Gains FDA Clearance for GEO FirstFuse MTPJ Fusion Plate

Gramercy Extremity Orthopedics (GEO) was granted FDA 510(k) clearance for the GEO FirstFuse MTPJ Fusion Plate, an indication-specific system to achieve arthrodesis of the first metatarsophalangeal joint in the foot. Plates and screws are individually sterile-packed and complemented by single-use, disposable instrument kits. This marks GEO's first plating system.

Limited launch is slated for 2H20.

GEO FirstFuse offers an array of plate size options that accommodate a range of cortical locking and cortical and cancellous non-locking screws.

Scott Day, Chief Commercial Officer, said, “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.”

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory