"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Inclusion Criteria:

• Patient is skeletally mature aged 22-70.

• Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1but the discogenic pain must be limited to a single level.

• Patient has adequate disc height (6mm) at the level to be treated

• Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).

• Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100points (40/100)

• Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)

• Patient has signed the approved Informed Consent Form.

• All surgeries must be approved by the Medical Advisory Board (MAB)

Exclusion Criteria:

• Patient has less than 6 mm of disc height.

• Patient has had prior lumbar spine surgery (nucleoplasty at non-index level isconsidered acceptable).

• Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces.Cervical fusion is allowed as long as there are no neurologic deficits in the lowerextremities.

• Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.

• Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.

• Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target levelaccording to SIS guidelines (diagnostic, contrast controlled).

• Patient has any known active malignancy.

• Patient has previously undergone or currently on immunosuppressive therapy. Steroidsused to treat inflammation are allowed.

• Patient has active or local systemic infection.

• Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupuserythematosus, or other autoimmune disease including AIDS, ARC and HIV.

• Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.

• Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan shouldbe performed to rule out patients considered at risk for osteopenia.

• Patient has morbid obesity defined as a body mass index (BMI) more than 40 or aweight of more than 45 kg (100 lbs.) over ideal body weight.

• Patient has a known allergy to silicone or barium sulfate.

• Patient has a significant disc herniation at the level to be treated. Significant isdefined as a large, extruded herniation that creates a risk for expulsion.

• Patient has a significant Schmorl's node in the level to be treated. Significant isdefined as a large, rectangular or irregular shaped node that has an associatedactive inflammatory process (Modic I changes).

• Patient has motion of less than 3 degrees on pre-operative lateral flexion/extensionradiographs.

• Patient belongs to a vulnerable population or has a condition such that his/herability to provide informed consent, comply with follow-up requirements, or provideself-assessments is compromised (e.g. developmentally, disabled, prisoner, chronicalcohol/ substance abuser)

Intraoperative Exclusion Criteria:

• Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of thevertebra during the imaging steps.

• Patient has a violated endplate as determined by imaging balloons duringfluoroscopy.

• Patient has a disc space that is too narrow for implantation. MIPL Specific

• Poor radiological visualization of Kambin's triangle.

• Sustained irritation of the exiting nerve root during any aspect of the annulardilation technique (leg movement or if performing with electrical monitoring) inspite or repositioning instruments.