Freedom® Lumbar Disc (FLD)
The FLD is a one-piece total disc replacement device. A special plastic (silicone polycarbonate urethane polymer) is bonded in between two metal plates. A metal cap locks into each plate.
The FLD looks like this:
The FLD system includes two end caps that engage the retaining plates through the apertures. The bone interface side of each end cap has a primary fin and two transverse rails that provide short term fixation with the vertebral endplates. The polymer interface side of the end cap is domed to provide support to the core under high loads.
Retaining plates are porous coated with titanium beads. The polymer interface side of each retaining plate is also bead coated for mechanical adhesion to the polymer core. Each retaining plate has a circular aperture, where end caps are placed.
The FLD is intended to relieve low back pain by replacing intervertebral discs that have been damaged by degenerative disc disease. The FLD device has been used in England and Germany in 50 patients in a clinical study. Researchers are still studying the long term effects of the FLD in these patients. No clinical studies have been done on the FLD in the U.S. before this FDA study.