Captiva Spine’s MIS Pedicle Screw Systems Receive Additional FDA Clearance
By Captiva Spine Inc. | March 8, 2016
New clearance covers larger diameter pedicle screws.
TowerLOX MIS Pedicle Screw System - PivoQuik Inserter Animation from Captiva Spine on Vimeo.
Captiva Spine Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for larger diameter screws within their Towerlox MIS pedicle screw system and Caplox II pedicle screw system. The additions to their systems include 8.5 mm and 9.0 mm polyaxial screws (non-cannulated, cannulated and reduction) for MIS (minimally invasive surgical), mini-open and open cases in 30 mm-100 mm lengths, while maintaining all of the same instrument compatibilities to the implant. The expansion of Captiva Spine’s line of cannulated and non-cannulated pedicle screws is an example of the company’s promise to continuously provide improvements and enhanced capabilities on behalf of surgeons and patients.
“We are pleased to know that after successfully supporting over 5000 surgeries with Captiva Spine pedicle screws, that surgeons have come to know our company as providing thoughtful and elegant systems combined with reliable solutions for the growing and diverse clinical needs in spine care,” said Dale Mitchell, president and founder of Captiva Spine.
During the recent introduction of the newest MIS rod inserters, Captiva Spine’s director of research and development, Dennis Ty, said “Pivoquik and Pivorod LP inserters have been performing as expected, which has resulted in a bigger than expected demand for our reliable rod inserter tools and method.”
Captiva Spine has recently updated their Towerlox web page to include the system enhancements and a new animation to show the Pivoquik inserter in action (above).