Tyber Medical, a US-based medical device company, has obtained 510(k) approval from the US Food and Drug Administration for its headless cannulated trauma screw system.
The headless screws are indicated for use throughout the human body in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation.
According to Tyber Medical, the FDA marketing approval allows the company’s private label customers to choose from the industry’s broadest range of trauma screw sizes ranging from 1.5-9.0mm in diameter.
The headless compression screw has a titanium or stainless steel body with short, long or full threads packaged either sterile or non-sterile. The self-drilling and self-tapping screws offered with either Torx or hex connection.
Tyber Medical sales manager Stu Shank said that this 510(k) clearance adds over 9,000 devices to the company’s growing product portfolio.
Waco Hand, Elbow & Wrist in Waco, Texas, president and orthopedic hand surgeon Dr John Faillace said that headless screws are ideal for reducing comminuted fractures to fewer fragments before plating.
"I use headless compression screws for a variety of conditions from arthrodesis to fracture repair. The Tyber Medical trauma screw system is designed to fit all these applications in a single platform," Dr Faillace added.
Image: Tyber Medical’s headless cannulated trauma screw system. Photo: Courtesy of PRNewswire/ Tyber Medical, LLC