US-based BioMedical Enterprises (BME) has obtained the US Food and Drug Administration (FDA) clearance (K131640) for its upgraded HammerLock Nitinol intramedullary fixation system for hammertoe deformities.
The patent-pending HammerLock intramedullary fixation system is made up of shape memory metal Nitinol and is intended for hammertoe deformities. This system eliminates the use of wires.
The HammerLock features a flat body design that resists rotation, barbs to provide secure fixation and high strength. The tabbed HammerBlock insertion system enables fast, simple and precise placement of the HammerLock implant.
The upgraded HammerLock features a linear body design which allows greater bone fusion area at the joint interface, enhanced flexibility in positioning and easier reduction. The Squeeze-Tab retention system further simplifies the insertion process.
BME president and CEO Keith M Peeples said: "This new design demonstrates our commitment to both developing new products and improving our existing lines."
BME surgeon consultant Dr Todd Stewart noted 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," Dr Stewart added.
The upgraded HammerLock intramedullary fixation system will be available for clinical use in the near future.