MOTUS Total Joint Replacement Investigational Device Exemption Study

Inclusion Criteria:

1. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy

2. 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. Symptomaticlumbar degeneration that may be associated with a co-morbid condition such as:

3. Herniated nucleus pulposus

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

5. Facet joint degeneration/osteophyte formation

6. Spondylosis (defined by the presence of osteophytes)

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

8. Lumbar stenosis defined by spinal cord or nerve root compression

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

10. Preoperative Oswestry Disability Index score ≥ 40/100 at baseline

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

12. 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 index level

5. Congenital bony and/or spinal cord abnormalities at the index level

6. Subcaudal defect, disrupting the integrity of the pedicle

7. Clinically compromised vertebral bodies at the index 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 an MRI scan, 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 5 years

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 DSM-5 (Diagnostic and Statistical Manual) 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.