Edge Orthopaedics, a new entry into the orthopedic medical device space, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its BITE compression screws.
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. The company is expected to fully launch the products in the second half of 2014 as it receives additional 510(k) approvals.
EDGE Orthopaedics president and chief scientific officer Dr Stephen Brigido noted compression screws are used in approximately 90% 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," Dr Brigido added.
The company has embarked on building a robust quality system and developing a platform of products that once on the market could make an immediate impact.