BME Receives FDA Clearance for the Upgraded HammerLock Intramedullary Fixation System for Hammertoe Deformities
BME Inc. (BioMedical Enterprises Inc.) is the privately held U.S. leader in shape memory technology medical devices for small bone fixation, and the first and only U.S.-based manufacturer of Nitinol implants for use in the foot, hand, and wrist. As part of its ongoing effort to develop new and innovative technologies, BME today announces the recent FDA clearance (K131640) of an upgrade to the patent-pending HammerLock Nitinol Intramedullary Fixation System.
Made of the shape memory metal Nitinol, the HammerLock Intramedullary Fixation System is used for hammertoe deformities eliminating the use of wires. The HammerLock features a flat body design that resists rotation, barbs to provide secure fixation and high strength. In addition, the patent-pending tabbed HammerBlock Insertion System allows for fast, simple and precise placement of the HammerLock implant. The upgraded HammerLock is designed with a linear body that results in a greater bone fusion area at the joint interface, enhanced flexibility in positioning and easier reduction. In addition, the insertion process is further simplified by the new Squeeze-Tab Retention System.
"This new design demonstrates our commitment to both developing new products and improving our existing lines," states Keith M. Peeples, BME president and CEO.
BME Surgeon Consultant, Todd Stewart, DPM, also explains, "The upgraded HammerLock system is a simple but very impressive improvement. This offers the surgeon easier insertion, prevents gapping at the arthrodesis site, and the new tab has just the right tension for keeping it on during reduction and for easy removal."
The new, upgraded BME HammerLock Intramedullary Fixation System will be available soon for clinical use.
Source: BME Inc.