To substantiate the clinical benefits of this Carbon/PEEK pedicle screw
system, we have initiated a prospective, multicenter clinical study in 2014.
Food and Drug Administration (FDA) to market its enhanced TowerLOX MIS Pedicle Screw
5mm (each 05),Titanium Polyaxial Pedicle screw
- Width 6.
SpineGuard has entered a co-development partnership with Zavation for the integration of its Dynamic Surgical Guidance (DSG) technology into Zavation's pedicle screw
In this study, pedicle fixation was defined as a pedicle screw
construct if more than 80% of the anchors used were screws.
Abstract: The paper presents a finite element analysis of three insertion directions of pedicle screw
in lumbar vertebra, the purpose being to investigate the impact of the implantation trajectory over the stability of vertebral pedicle-screw interface, by comparing the maximal displacements obtained for the same pull-out force.
The patients were randomized to a 1-year exercise program, posterolateral fusion surgery without pedicle screw
instrumentation, or fusion with pedicle screw
In addition, the agreement includes rights to the C 3 Cervical Plate System, an anterior plating system that is designed to aid in achieving fusion in the cervical spine, and the Uni-Thread Lumbar System, which would be the first single threaded pedicle screw
system that offers both a polyaxial and lateral linking in one system designed to provide stabilization of the spine in low back procedures.
The plaintiffs alleged that the hospital failed to "warn patients that the Food and Drug Administration (FDA) had specifically rejected the pedicle or back screws and/or plates (and other hardware) for implantation in the spine;" that the defendant hospital failed to "warn plaintiff that the pedicle screw
devices, cages, and hardware implanted in her spine .
The associations allegedly conspired with the manufacturers to mislead physicians into using the pedicle screw
by offering industry-supported seminars on the use of the device and engaging in various other concerted activities, including allowing pedicle screw
manufacturers to exhibit at scientific exhibitions run by the associations.
The FDA estimates that 350,000 people may already have received pedicle screw
implants, and the agency's medical experts report that the screws can be expected to break in about 5 percent of patients.
The European market for minimally invasive spinal implants includes minimally invasive pedicle screw
systems and minimally invasive interbody devices.