Gramercy Extremity Orthopedics Receives FDA 510(k) Clearance for GEO Bone Screw

By Julie A. Vetalice

Gramercy Extremity Orthopedics (GEO) received FDA 510(k) clearance to market the GEO™ Bone Screw, indicated for fractures, osteotomies, arthrodesis, osteochondritis and tendon reattachment. This is the company's first 510(k) clearance.

The GEO system comprises an array of low-profile titanium screw lengths, diameters, thread lengths and fully-threaded options. Screws are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads and a hexalobe head to provide additional stability and torque transfer with less potential for head stripping.

Instruments are also double sterile packaged in single use kits.

GEO was formed with the objective to lower real operating costs by creating efficiencies and controls throughout delivery and consumption of orthopaedic implants.

Source: Gramercy Extremity Orthopedics LLC

Tags: 510(k) Clearance, Regulatory