Inclusion Criteria:
1. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
2. Subject plans to undergo a one-level Open or Mini-Open TLIF procedure (stabilized with
pedicle screws) independent of this research protocol;
3. Subject is to be treated with on-label use of an FDA-cleared TLIF cage and pedicle
screw system independent of this research protocol;
4. The subject has a primary diagnosis of symptomatic lumbar degeneration with or without
foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1
confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more
than a Grade 1 (<25% translation) spondylolisthesis. Symptomatic lumbar degeneration
that may be associated with a co-morbid condition such as:
1. Herniated nucleus pulposus;
2. Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint
capsule;
3. Facet joint degeneration/osteophyte formation;
4. Spondylosis (defined by the presence of osteophytes);
5. Disc degeneration and/or annular degeneration; and/or. 6. Lumbar stenosis defined by spinal cord or nerve root compression;
5. Exhausted conservative treatment (e.g. bed rest, physical therapy, medications,
transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal
injections) for at least 3 months or has a neurologic emergency;
6. Preoperative Oswestry Disability Index score > 40/100 at baseline;
7. Preoperative total leg pain and/or total back pain score > 40/100 on the Visual Analog
Scale at baseline;
8. Surgical candidate for a posterior approach to the lumbar spine;
9. Psychosocially, mentally and physically able and willing to fully comply with this
protocol including adhering to follow-up schedule and requirements and filling out
forms; and. 10. Signed informed consent.
Exclusion Criteria:
1. More than one vertebral level requiring treatment;
2. Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion,
interspinous device, etc.) at the index lumbar level or an adjacent level;
3. Degenerative or lytic spondylolisthesis greater than Grade 1 (<25% translation);
4. Rotatory scoliosis at the level to be treated;
5. Congenital bony and/or spinal cord abnormalities at the level to be treated;
6. Subcaudal defect, disrupting the integrity of the pedicle;
7. Clinically compromised vertebral bodies at the involved level due to current or past
trauma, e.g., by the radiographic appearance of the fracture callus, malunion or
nonunion;
8. Disrupted anterior longitudinal ligament at the index level;
9. Overlying thoracolumbar kyphosis within one level (includes target and adjacent level)
of the level to be treated;
10. Back pain of unknown etiology without leg pain;
11. Severe spondylosis at the level to be treated as characterized by any of the
following:
1. Autofusion (solid arthrodesis) determined radiographically (CT);
2. Totally collapsed disc, or;
3. Vertebral body that cannot be mobilized;
12. Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or
vitamin E;
13. Unable to undergo an MRI scan, CT scan or other radiograph assessments;
14. Osteopenia: All patients will complete SCORES/MORES to screen if a dual energy x-ray
absorptiometry (DEXA) scan is indicated. If DEXA is required, exclusion will be
defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if
completed within 6 months of subject screening;
15. Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.:
Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis
imperfecta);
16. Insulin-dependent diabetes mellitus;
17. Lactating, pregnant or interested in becoming pregnant in the next 3 years;
18. Active infection
Any medical condition requiring treatment with any drug known to potentially interfere
with bone/soft tissue healing or receiving radiation therapy that is expected to
continue for the duration of the study;
20. Body Mass Index > 40;
21. Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or
thromboembolic disease;
22. Systemic disease including Lupus disease, Reiter's disease, Rheumatoid disease, AIDS,
HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy,
including biologics, for systemic inflammation;
23. Spinal tumor;
24. Active malignancy: A patient with a history of any invasive malignancy (except
non-melanoma skin cancer), unless he/she has been treated with curative intent and
there have been no clinical signs or symptoms of the malignancy for at least 5 years;
25. Any degenerative muscular or neurological condition that would interfere with
evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic
lateral sclerosis (ALS), or multiple sclerosis;
26. Has chronic or acute renal and/or hepatic impairment and/or failure or prior history
of renal and/or hepatic parenchymal disease;
27. Has a Waddell Signs of Inorganic Behavior score of 3 or greater;
28. In the opinion of the investigator, the subject has a behavioral, cognitive, social or
medical problem that may interfere with the assessment of the safety or effectiveness
of the device;
29. Current or recent history of chemical/alcohol abuse or dependency using standard
medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
code;
30. Currently smoking or using tobacco products, including e-cigarette products (e.g.,
vaping);
31. Currently pursuing or in active spinal litigation for medical negligence, or trauma,
or workers compensation;
32. Is a prisoner, incarcerated, or has been coerced to participate in the study that
could impact the validity of results;
33. Is currently participating in an investigational therapy (device and/or
pharmaceutical) within 30 days prior to entering the study or such treatment is
planned during the 24 months following enrollment into the study.