Trax Surgical, a company based in Massachusetts that specialises in orthopaedic product development and distribution, has announced receiving US Food and Drug Administration (FDA) 510(k) clearance to market its LINKT Compression Staple System.
This system provides a selection of nitinol staples designed for procedures such as fracture repair, joint fusion, and osteotomy.
The nitinol staples offer an intraoperative advantage by simplifying and speeding up application due to fewer steps involved.
The staple’s compressive properties facilitate a stable environment conducive to bone healing.
According to Trax Surgical, the LINKT Compression Staple System presents advancements over older models that lack pre-implantation adjustability. The system includes an adjustable inserter that allows surgeons to manipulate the staple’s legs for easy insertion.
Multiple staples can be placed using an appropriately sized inserter, which also assists in implant seating, removal, or repositioning.
Trax Surgical president Shane Shankle said: “We are incredibly excited about this advancement.
“The approval of our Nitinol Compression Staple enables us to better serve our customers and elevate the standard of care in extremity orthopaedics. It reflects our dedication to innovation, quality, and the needs of both surgeons and patients.”
The nitinol staples from Trax Surgical feature a slightly curved bridge to ensure even compression across the fusion site and come with toothed legs for secure fixation. The LINKT Staples are available in various bridge widths and leg lengths.
The system includes individually packaged sterile staples and sterile deployment kits containing a drill, drill guide, locating pins, and inserter.
Trax Surgical manufactures medical instruments and implants for surgeries involving the upper and lower extremities. The development of the Trax Compression Screw System was initially undertaken by Primo Medical Group.
