The PRODISC® Total Disc Replacement is an artificial intervertebral disc made from metal and plastic that is used to treat pain associated with degenerative disc disease (DDD).

DDD is defined as discogenic back pain (pain resulting from a degenerated intervertebral disc) with degeneration of the disc confirmed by patient history and radiographic studies.

The PRODISC® Total Disc Replacement is implanted to replace a diseased or damaged intervertebral disc during a surgical procedure called spinal arthroplasty.

The PRODISC® Total Disc Replacement consists of three parts:

1. Two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the spinal bones (vertebrae)

2. A plastic (ultra-high molecular weight polyethylene, or UHMWPE) inlay that fits between the two endplates

3. The plastic inlay and endplates help restore the natural distance between the two vertebrae (disc height). The top (superior) endplate can slide over the domed part of the inlay, which can allow movement at the level where it is implanted.

The PRODISC®-L Total Disc Replacement is indicated for spinal arthroplasty in patients who:

• are skeletally mature
• have degenerative disc disease (DDD) at one level in the lumbar spine (from L3-S1) or at one level in the cervical spine (from C3-C7)
• have no more than Grade 1 spondylolisthesis at the involved level
• have had no relief from pain after at least six months of non-surgical treatment

The device may restore disc height, may reduce pain, and may allow movement at the level where it is implanted. The basic principle of the PRODISC® is to restore at least the natural range of mobility and stability in terms of: flexion and extension, lateral bending, and axial rotation and compression.