Trax Surgical Receives FDA 510(k) Clearance for Nitinol Staple System

STOUGHTON, Mass., May 19, 2025 /PRNewswire/ -- Massachusetts based Trax Surgical, LLC, an orthopedic product development and distribution company principally serving the needs of the orthopedic extremities market, announced today that they received FDA 510(k) clearance to market the LINKT™ Compression Staple System. The staple system offers a range of nitinol staples for fracture repair, joint fusion, and osteotomy procedures.

Compression bone staples have a key intraoperative advantage in that they are technically easier and faster to apply as fewer steps are required. This is an important option for surgeons to have when assessing the needs of their patients. Trax Surgical's nitinol staple with inherent compressive properties creates a stable environment that promotes bone healing.  "We are incredibly excited about this advancement," said Shane Shankle, President of Trax Surgical. "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."

The LINKT Compression Staple System is an improvement over some outdated designs that lack the ability to adjust the staple prior to implantation. The LINKT System features an adjustable inserter that allows the surgeon to open and close the staple's legs for easy insertion. Multiple staples can be deployed with an appropriately sized inserter, which is also used to properly seat the implant, or to remove and reposition it.

The company's nitinol staples have a slightly curved bridge designed to provide more even compression across the fusion site and feature toothed legs for secure fixation. LINKT Staples are available in multiple bridge widths and leg lengths. The LINKT system is comprised of staples sold individually in sterile packaging, and sterile deployment kits comprised of a drill, drill guide, locating pins, and inserter.

About Trax Surgical

Trax Surgical manufactures innovative medical instrumentation and implant devices for surgical procedures involving the upper and lower extremities. They engineer premium medical products with patient comfort and durability in mind for internal fixation, reconstruction, and more. Bone and fracture repair products from Trax Surgical are quality-assured and certified to industry standards.  The Trax Compression Screw System was initially developed by Primo Medical Group. Trax Surgical partners with Primo Medical Group to deliver innovative new products and medical devices certified to industry standards for surgical procedures.

About Primo Medical Group

Primo Medical Group offers the most comprehensive outsourcing solutions for the medical device market, including OEM product distribution services, engineering services, precision component production, finished goods assembly, medical device refurbishment, reusable surgical kit management and complete supply chain management. Established in 1953, Primo Medical Group is a privately held company with five facilities in Massachusetts. Primo Medical Group is an FDA Registered Contract Manufacturer and is compliant with FDA Quality Systems Regulations. Primo Medical Group is also ISO 13485:2016 certified and is a registered manufacturer with the Office of Defense Trade Controls Compliance. Over the past 24 years Primo Medical Group has incubated and co-funded several new technologies including Angiolink, (acquired by Medtronic), Arthrosurface, Spirus Medical, (acquired by Olympus), Cardiosolutions, Saphena Medical (Acquired in 2024), Versago Vascular Access, Trax Surgical, and Solid State Marine.

Contact:                    
Andrea Patisteas
Senior Executive Vice President
Trax Surgical    

SOURCE Trax Surgical