GEO's bone screw system wins FDA 510(k) clearance
Gramercy Extremity Orthopedics (GEO) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its GEO bone screw system.
The system can be used for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachments.
GEO bone screw system is said to provide a range of low profile titanium screw lengths, diameters, thread lengths and fully threaded options.
The screws of the system are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads.
It also includes hexalobe head to offer additional stability, as well as torque transfer with less potential for head stripping.
In addition, all instruments of the GEO system are double sterile packaged in single use kits.
Gramercy noted that the approval marks a major milestone for the company, as the system is the first offering from its product line.
The company will exhibit the new system at the CFAS Scientific Conference in Las Vegas, which will be held from 27 February to 1 March.
Gramercy Extremity Orthopedics president and CEO Michael Simpson said: "We are very pleased with the clearance of the GEO Bone Screw System.
"GEO is in the business of providing solutions to complex problems for our customer, and this clearance is one more step in that offering."
The company is engaged in the development of sterilized single use orthopedic implants and instruments.