3Spine Lumbar Fusion Real World Evidence Study

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 or PLIF 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 or PLIF cage(s)and pedicle screw system independent of this research protocol;

4. The subject has a primary diagnosis of symptomatic lumbar degeneration with orwithout foraminal or recess stenosis of the lumbar spine at a single level fromL1/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 conditionsuch as:

5. Herniated nucleus pulposus;

6. Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet jointcapsule;

7. Facet joint degeneration/osteophyte formation;

8. Spondylosis (defined by the presence of osteophytes);

9. Disc degeneration and/or annular degeneration; and/or

10. Lumbar stenosis defined by spinal cord or nerve root compression;

11. Exhausted conservative treatment (e.g. bed rest, physical therapy, medications,transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinalinjections) for at least 3 months or has a neurologic emergency;

12. Preoperative Oswestry Disability Index score >/= 40/100 at baseline;

13. Psychosocially, mentally and physically able and willing to fully comply with thisprotocol including adhering to follow-up schedule and requirements and filling outforms; and

14. 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 pasttrauma, e.g., by the radiographic appearance of the fracture callus, malunion ornonunion;

8. Disrupted anterior longitudinal ligament at the index level;

9. Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within onelevel (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 thefollowing:

12. Autofusion (solid arthrodesis) determined radiographically (CT);

13. Totally collapsed disc, or;

14. Vertebral body that cannot be mobilized;

15. Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, orvitamin E;

16. Unable to undergo a CT scan or other radiograph assessments;

17. Osteopenia: The SCORE/MORES will be utilized for all females age <50 and males age <55 to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXAscan is required. A DEXA scan is indicated for all females age ≥50 and all males age ≥55. If DEXA is required, exclusion will be defined as a DEXA bone density measuredT score ≤ -1. An existing DEXA is allowed if completed within 6 months of subjectscreening;

18. Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesisimperfecta);

19. Insulin-dependent diabetes mellitus;

20. Lactating, pregnant or interested in becoming pregnant in the next 3 years;

21. Active infection - systemic or local;

22. Any medical condition requiring treatment with any drug known to potentiallyinterfere with bone/soft tissue healing or receiving radiation therapy that isexpected to continue for the duration of the study;

23. Body Mass Index > 40;

24. Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, orthromboembolic disease;

25. 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;

26. Spinal tumor;

27. Active malignancy: A patient with a history of any invasive malignancy (exceptnon-melanoma skin cancer), unless he/she has been treated with curative intent andthere have been no clinical signs or symptoms of the malignancy for at least 5years;

28. Any degenerative muscular or neurological condition that would interfere withevaluation of outcomes, including but not limited to Parkinson's disease,amyotrophic lateral sclerosis (ALS), or multiple sclerosis;

29. Has chronic or acute renal and/or hepatic impairment and/or failure or prior historyof renal and/or hepatic parenchymal disease;

30. Has a Waddell Signs of Inorganic Behavior score of 3 or greater;

31. In the opinion of the investigator, the subject has a behavioral, cognitive, socialor medical problem that may interfere with the assessment of the safety oreffectiveness of the device;

32. Current or recent history of chemical/alcohol abuse or dependency using standardmedical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code;

33. Currently smoking or using tobacco products, including e-cigarette products (e.g.,vaping); (Use within 30 days of surgery date is considered 'current');

34. Currently pursuing or in active spinal litigation for medical negligence, or trauma,or workers compensation;

35. Is a prisoner, incarcerated, or has been coerced to participate in the study thatcould impact the validity of results;

36. Is currently participating in an investigational therapy (device and/orpharmaceutical) within 30 days prior to entering the study or such treatment isplanned during the 24 months following enrollment into the study.