PRODISC® L Total Disc Replacement

Division: Spine
Category: Interbody

The PRODISC® L Total Disc Replacement is intended to replace a diseased and/or degenerated intervertebral disc of the lumbosacral region in patients with discogenic pain associated with degenerative disc disease (DDD) at one lumbar spinal segment between L3 and S1. Total disc replacement is intended to significantly reduce discogenic pain and improve patient function by allowing for the removal of the diseased disc while restoring the normal disc height.

The PRODISC L Total Disc Replacement design is based on a ball-and-socket principle composed of three implant components—two cobalt chrome alloy (CoCrMo) end plates and an ultra-high-molecular-weight polyethylene (UHMWPE) inlay. The polyethylene inlay includes a radiopaque tantalum market. PRODISC L Total Disc Replacement end plates have central keels and small spike for initial fixation to the vertebral bodies and a plasma sprayed titanium coating on all bone contacting surfaces to promote bony integration.

Indications for Use

INDICATIONS

 

The PRODISC® L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than grade 1 spondylolisthesis at the involved level. Patients receiving the PRODISC L Total Disc Replacement should have failed at least 6 months of conservative treatment prior to implantation of the PRODISC L Total Disc Replacement.

 

CONTRAINDICATIONS

 

The PRODISC L Total Disc Replacement should not be implanted in patients with the following conditions:

 

  • Active systemic infection or infection localized to the site or implantation
  • Osteopenia or osteoporosis defined as DEXA bone density measured T-score < -1.0
  • Bony lumbar spinal stenosis
  • Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium, tantalum)
  • Isolated radicular compression syndromes, especially due to disc herniation
  • Pars defect
  • Involved vertebral end plate dimensionally smaller than 34.5 mm in the medial-lateral and/or 27 mm in the anterior-posterior directions
  • Clinically compromised vertebral bodies at affected level due to current or past trauma
  • Lytic spondylolisthesis or degenerative spondylolisthesis of grade > 1

Features & Benefits

  Features Benefits




PRODISC L Total Disc Replacement | DePuy Synthes

PRODISC L Total Disc Replacement patented central keel, lateral spikes | DePuy Synthes

PRODISC L Total Disc Replacement plasma-sprayed titanium coating | DePuy Synthes

 

Ball-and-socket design

Controlled and predictable motion

 

Semi-constrained

 

Fixed center-of-rotation

Patented central keel, lateral spikes

Provides immediate stability in three planes and facilitates midline placement

 

Provides secure primary fixation

Plasma-sprayed titanium coating

Covers all bone contacting surfaces

Proven materials

The materials used as the articulating surfaces of PRODISC L 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 enables accurate sizing and placement of the implant

Streamlined instrumentation

Designed for midline, mini-open anterior approach

 

Enables clear visualization into the disc space

 

DSUS/SPN/0616/1353 7/2016

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.