LDR Receives FDA 510(k) Clearance for LP Multiaxial Screw
November 28, 2006
Innovative Easyspine® System now offers a reduction and offset screw
AUSTIN, Texas (November 28, 2006)—LDR, a total spine solution company, announced today that it has obtained 510(k) clearance from the United States Food and Drug Administration to market its LP Multiaxial Screw. The LP Screw adds valuable flexibility to the Easyspine® Pedicle Screw System allowing 70° of movement in all planes, while simplifying spondylolisthesis reduction and offset screw placement.
The LP Screw performs a spondylolisthesis reduction in two stages with very minimal instrumentation. During boney reduction, the LP is driven into the bone, pulling the vertebra toward the rod. Final mechanical reduction allows 6-10mm of calibrated adjustment during locking of the integrated locking nut.
Dr. Kee Kim of the University of California-Davis Medical Center was the first in the U.S. to implant an LP Screw. Dr. Kim comments, “It is important for surgeons to have multiple options when doing lumbar fusion surgery. The addition of the LP Screw strengthens an already innovative fusion product line by adding an offset option along with a simple way to do a solid spondylolisthesis reduction.”
The LP Screw contains one multiaxial and one polyaxial connection: the head-to-rod connection and the head-to-shaft connection. Both connection points lock independently for maximum adjustability. This combined connection design creates the generous range of motion of 70°. The distance from the screw shaft to rod provides a built-in offset of 10mm.
Christophe Lavigne, CEO of LDR, comments, “LDR is often identified with innovative non-fusion products, due to our extensive experience with the Mobi-C® Cervical and Mobidisc® Lumbar artificial discs. However, our company also creates strong fusion products, and the LP Screw is an exciting addition to our overall product offering.
Easyspine was first introduced in 2002 and has been used in over 10,000 cases worldwide. Designed in close cooperation with leading spine surgeons, Easyspine features a simplified surgical technique and adaptable implants to accommodate varied pathologies.
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com