HAMMERTOE DEVICE GAINS FDA CLEARANCE (Orthopedics This Week)
A device for treating hammertoe deformities has received FDA clearance. Called the HammerLock Nitinol Intramedullary Fixation System, the device is manufactured by the privately held BioMedical Enterprises, Inc. (BME), San Antonio, Texas.
Company officials report that the device eliminates the use of wires and features a flat body design that resists rotation. In addition, the device has barbs that provide a secure fixation. According to PR Newswire this upgraded version of HammerLock is designed with a linear body that results in a greater bone fusion area at the joint interface which help improve flexibility in positioning and easier reduction. The insertion process is simplified by the new Squeeze-Tab Retention System.
“This new design demonstrates our commitment to both developing new products and improving our existing lines,” said Keith M. Peeples, BME president and CEO. BME surgeon consultant, Todd Stewart, DPM, stated, “The upgraded HammerLock system is a simple but very impressive improvement.” BME, Inc. is the only U.S. manufacturer of Nitinol metal implants for musculoskeletal and soft tissue fixation.