EDGE™ Orthopaedics Receives First FDA 510(k) Clearance

New entrant into the orthopaedic device space, EDGE Orthopaedics has its first FDA 510(k) Clearance in the form of a range of compression screws.

Background

Never heard of EDGE™ Orthopaedics? Neither had we, which is unsurprising given that the company only came into existence in 2012. EDGE has announced receipt of its first FDA 510(k) clearance for BITE™ Compression Screws which it will be hoping stand out from the crowd by virtue of a comprehensive range of sizes in both headed and headless options – not to mention an extremely low profile head and better “BITE”.

With the first cases under its belt and a pipeline of products in development, EDGE Orthopaedics is embarking on a limited launch Q2. A full launch is expected in the second half of 2014 as they receive additional 510(k) clearances.

The company’s teaser website offers no clue as to what its BITE screws look like yet, but promises much excitement and is doing as much as a website can to create a buzz about itself.

Company comments

According to Dr. Stephen Brigido, President and CSO of EDGE Orthopaedics, “compression screws are used in approximately 90% of foot and ankle procedures and are the backbone of every orthopedic extremity company”.

Source: Edge Orthopaedics, PR Newswire

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