06.05.14
Morristown, N.J.-based Tyber Medical LLC has been granted 510(k) clearance from the U.S. Food and Drug Administration for a cornerstone device for any orthopedic technology company: a headless cannulated trauma screw system.
Tyber Medical’s private label customers will now be able to choose from a range of trauma screw sizes from 1.5 mm to 9 mm in diameter. These screws are indicated for use throughout the human body in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation.
“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,” said John J. Faillace, M.D., orthopedic hand surgeon and president at Waco Hand, Elbow & Wrist in Waco, Texas. “The Tyber Medical trauma screw system is designed to fit all these applications in a single platform.”
The Tyber Medical headless compression screw features a titanium or stainless steel body with short, long or full threads packaged either sterile or non-sterile. The screws are self-drilling and self-tapping and are offered with either Torx or hex connection.
“This 510(k) clearance adds over 9,000 devices to our growing product portfolio,” said Stu Shank, sales manager for Tyber. “Tyber Medical’s broad selection will allow our customers to differentiate themselves by offering the correct screw size for each indication.”
Tyber Medical orthopedic and spine devices.
Tyber Medical’s private label customers will now be able to choose from a range of trauma screw sizes from 1.5 mm to 9 mm in diameter. These screws are indicated for use throughout the human body in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation.
“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,” said John J. Faillace, M.D., orthopedic hand surgeon and president at Waco Hand, Elbow & Wrist in Waco, Texas. “The Tyber Medical trauma screw system is designed to fit all these applications in a single platform.”
The Tyber Medical headless compression screw features a titanium or stainless steel body with short, long or full threads packaged either sterile or non-sterile. The screws are self-drilling and self-tapping and are offered with either Torx or hex connection.
“This 510(k) clearance adds over 9,000 devices to our growing product portfolio,” said Stu Shank, sales manager for Tyber. “Tyber Medical’s broad selection will allow our customers to differentiate themselves by offering the correct screw size for each indication.”
Tyber Medical orthopedic and spine devices.