Diamond Orthopedic Announces FDA Clearance for Sterile Faceted Screw

By Julie A. Vetalice

Diamond Orthopedic received FDA 510(k) clearance for sterile packaged faceted bone screws in headless compression, cortex and cannulated screws, pins and guidewires. The clearance supports Diamond’s strategy to penetrate the orthopaedic ambulatory surgery center market.

The company's patented screw design enables screw insertion into bone with less torque, and may lend better purchase at the bone/screw interface and reduced compressive stress vs. traditional helical screws.

Source: Diamond Orthopedic, LLC

Tags: 510(k) Clearance, Regulatory