Edge Orthopedics Gains First FDA Clearance

Boonton, N.J.-based Edge Orthopaedics, a new entry in the orthopedics device space, has received its first 510(k) clearance from the U.S. Food and Drug Administration. The first products from Edge to get the go-ahead from the FDA are its Bite compression screw for foot and ankle procedures.

According to Stephen Brigido, DPM, president and chief scientific officer of Edge, “compression screws are used in approximately 90 percent of foot and ankle procedures and are the backbone of every orthopedic extremity company. With a comprehensive range of sizes in both headed and headless options—not to mention an extremely low profile head and better “BITE”—Edge is building a strong foundation for future growth.”

With the first cases under their belt and a pipeline of products in development, Edge Orthopaedics is embarking on a limited launch in the second quarter of 2014. A full launch is expected in the second half of the year as they receive additional 510(k) clearances.

Established in 2012, Edge Orthopaedics is a privately held medical device company developing products and solutions for extremity orthopedics.