RTI Surgical, a surgical implant company, has secured expanded 510(k) clearance from the US Food and Drug Administration (FDA) for its Streamline OCT Occipito-Cervico-Thoracic System.
This clearance expands the indication for polyaxial screw placement to include the cervical spine, and also includes clearance for a dual diameter transition rod.
The system’s newly expanded indications span from the Occiput to T3, but additional levels of fixation can be accomplished by connecting to other RTI pedicle screw systems through the newly cleared transition rod or currently available rod-to-rod connectors.
“We are excited about the launch of the transition rod, as well as the receipt of the posterior cervical screw indication,” said Brian Hutchison, chief executive officer.
“These updates to our Streamline OCT System reflect our passion to deliver surgical solutions that provide a higher standard of patient care and deliver the highest value to our customers.”
RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants.
Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe.
RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed.