The PRODISC® C Total Disc Replacement is intended to replace a diseased and/or degenerated disc of the cervical spine in patients with symptomatic cervical disc diseases (SCDD). The PRODISC C Total Disc Replacement procedure is intended to significantly reduce pain by allowing for the removal of the diseased disc while restoring disc height and providing the potential for motion at the affected vertebral segment.
The PRODISC C Total Disc Replacement utilizes a ball and socket design similar to joint replacement devices that have been successfully used for many decades. The PRODISC C Total Disc Replacement implant is composed of three components—two cobalt chromium alloy (CoCrMo) endplates and an ultra-high molecular weight polyethylene (UHMWPE) inlay. The implant is an inserted en-bloc and is securely anchored in the spine with patented keel technology.
The PRODISC® C Total Disc Replacement is indicated in skeletally mature patients for reconstruction of a single disc from C3-C7 following discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The PRODISC-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the PRODISC C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the PRODISC C Total Disc Replacement.
The PRODISC C Total Disc Replacement should not be implanted in patients with the following conditions:
Correct placement of the device is essential to optimal performance. Use of the PRODISC C Total Disc Replacement should only be undertaken after the surgeon has become thoroughly knowledgeable about spinal anatomy and biomechanics, has had experience with anterior cervical spinal surgeries, and has had hands-on training in the use of this specific device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, including neurological complications. The safety and effectiveness of this device has not been studied in the pediatric or adolescent age group (<22 years old). Due to the proximity of vascular and neurological structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurological damage with the use of this device. Care should be taken to identify and protect these structures during surgery.
Controlled and predictable motion
|Patented central keel||
Facilitates midline placement
Provides immediate stability in three planes
|Plasma-sprayed titanium coating||
Covers all bone contacting surfaces
Promotes bony ongrowth for long term secondary fixation
|Proven materials||The materials used as the articulating surfaces of to PRODISC® C Total Disc Replacement have been used in spinal arthroplasty since 1987 and are the most commonly used articulating materials in total joint replacements|
|Safe and reproducible surgical technique||Three step implantation technique consisting of trialing, keel preparation and implantation|
Minimizes contact with local anterior soft tissue structures after implantation