Trax Surgical Achieves FDA Clearance for Innovative Nitinol Compression Staple System

Trax Surgical's Milestone Achievement

Massachusetts-based Trax Surgical, LLC, dedicated to the development and distribution of orthopedic products, recently announced a significant advancement in its offerings: the LINKT™ Compression Staple System has received FDA 510(k) clearance for marketing. This state-of-the-art system provides an impressive range of nitinol staples designed for various orthopedic applications including fracture repair, joint fusion, and osteotomies.

The LINKT System incorporates innovative design features that stand out in today's orthopedic landscape. It includes a nitinol implant complemented by specialized deployment tools, enabling surgeons to execute their procedures with greater efficiency and precision. One of the most notable benefits of using compression bone staples like those in the LINKT System is their operational simplicity. Surgeons can apply these staples with fewer procedural steps, saving valuable time in the operating room and improving patient outcomes.

Shane Shankle, President of Trax Surgical, expressed his enthusiasm regarding this development: "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 orthopedics. It reflects our dedication to innovation, quality, and the needs of both surgeons and patients."

A key improvement in the LINKT System lies in its adjustable inserter, allowing for real-time adjustments of the staple before implantation. This flexibility ensures that surgeons can easily open or close the staple’s legs during the insertion process. Furthermore, the design permits multiple staples to be deployed simultaneously using appropriately sized inserter tools. This not only optimizes the operation but also allows for the proper seating of the implant, and if necessary, the repositioning of the staples can be accomplished without complications.

The thoughtfully constructed nitinol staples feature a slightly curved bridge that provides even compression across the fusion site and toothed legs that ensure secure fixation. Surgeons can choose from various bridge widths and leg lengths to expertly tailor their approach to each patient’s unique anatomy. The staples are sold individually in sterile packaging, and the deployment kits that accompany them include essential tools such as drills, drill guides, and locating pins, all sterilized for immediate use.

About Trax Surgical

Founded with a commitment to delivering quality medical instruments for surgical applications, Trax Surgical is renowned for manufacturing innovative devices that enhance the treatment of both upper and lower extremities. Its product line includes state-of-the-art items engineered for internal fixation and reconstruction, all designed with patient safety and durability in mind. The company ensures its products meet industry standards through rigorous quality assurance practices.

Trax Surgical's overarching vision is supported by its partnership with Primo Medical Group, known for its comprehensive outsourcing solutions in the medical device sector, ranging from OEM product distribution to precision component production and complete supply chain management. Established in 1953, Primo Medical Group has gained a reputable position in the industry, contributing significantly to the development of advanced technologies and the certification of innovative products in compliance with FDA standards.

This latest FDA approval represents a pivotal moment for Trax Surgical, reinforcing its mission to innovate in the orthopedic field and ultimately enhance patient care during surgical procedures. As the LINKT System integrates into surgical practices, it holds the potential to transform orthopedic treatments and lead the way towards more efficient and effective surgical outcomes.