Trax Surgical today announced it received FDA 510(k) clearance to market its Linkt Compression Staple System.
According to the Stoughton, Massachusetts-based orthopedic product development and distribution company, the staple system provides a range of nitinol staples for fracture repair, joint fusion, and osteotomy procedures.
“We are incredibly excited about this advancement,” Trax Surgical President Shane Shankle said in a news release. “The approval of our Nitinol Compression Staple enables us to better serve our customers and elevate the standard of care in extremity orthopedics. It reflects our dedication to innovation, quality, and the needs of both surgeons and patients.”
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Compression bone staples are technically easier and faster to apply in fewer steps. Trax Surgical said Linkt’s nitinol staples have compressive properties that create a stable environment that promotes bone healing. Linkt’s design is an improvement over compression staple systems that do not allow for adjustment prior to implantation.
Linkt also has an adjustable inserter that allows the surgeon to open and close the staple’s legs for easy insertion. An appropriately sized inserter can deploy multiple staples and is also used to properly seat the implant or remove and reposition it.
Trax Surgical’s nitinol staples have a slightly curved bridge that it designed to provide even compression across fusion sites. They also have toothed legs for secure fixation and come in multiple bridge widths and leg lengths.
