The US Food and Drug Administration (FDA) has granted 510(k) clearance to Trax Surgical’s LINKT compression staple system for orthopaedic applications.
The system is designed to provide a range of nitinol staples for joint fusion, fracture repair, and osteotomy procedures.
Go deeper with GlobalData
According to the company, compression bone staples are easy and quick to apply, needing few steps, and its nitinol staple comes with compressive properties, creating an environment that supports bone healing.
The system’s adjustable inserter assists surgeons in opening and closing the staples’ legs for insertion and repositioning.
Its nitinol staples feature a slightly curved bridge to ensure even compression across the fusion area. Additionally, the toothed legs of the staples provide secure fixation.
The LINKT staples come in various bridge widths and leg lengths, catering to diverse surgical needs.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe company noted that each staple is available in sterile packaging, with deployment kits that include a drill, drill guide, locating pins, and inserter.
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.”
US-based Trax Surgical specialises in medical instrumentation and implant devices, particularly for surgeries involving the upper and lower extremities.
The company collaborates with Primo Medical Group to deliver medical devices and products for surgical use.
The group provides a range of outsourcing solutions for the medical device market. These include original equipment manufacturer (OEM) product distribution and engineering services, precision component production, medical device refurbishment, and finished goods assembly.
