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.Symptomatic lumbar degeneration that may be associated with a co-morbid conditionsuch 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, manipulation, and/or spinal injections) for at least 3 months or has aneurologic 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; and

12. Signed informed consent.

Exclusion Criteria:

1. More than one vertebral level requiring treatment with instrumentation;

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)associated with congenital (e.g. dysplastic) pars defects;

4. Rotatory scoliosis (>10 degrees) at the index level;

5. Congenital bony and/or spinal cord abnormalities at the level to be treated such asconjoined nerve roots that would otherwise prevent placement of the device withoutgenerating nerve damage or skeletal malformations such as kyphotic vertebra that maybe better suited for a different course of treatment (e.g. spinal fusion);

6. Subcaudal defect, disrupting the integrity of the pedicle that presents undue riskof device subsidence or migration due to compromised bone quality/density;

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 diagnosed by surgeon using a comprehensive assessment of all availableinformation including the following:

• DEXA bone density measured T-score ≤ -1:

• Females age <50 and males age <55: The SCORE/MORES will be utilized toscreen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXAscan is required.

• Females age ≥50 and all males age ≥55: DEXA scan is required.

• If indicated for DEXA, an existing scan is allowed if completed within 6months of subject surgery;

• Opportunistic quantitative CT (Hounsfield Units): Measurement is encouraged assupplemental information to determine potential for osteopenia;

• Intra-operative evaluation of bone quality to assess if there is a significantrisk for implant subsidence;

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

16. Insulin-dependent diabetes mellitus;

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

18. Active infection - systemic or local;

19. 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;

20. Body Mass Index > 40;

21. Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, orthromboembolic 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 at the index level or adjacent level that could compromise integrity ofthe implant (hemangiomas must be evaluated by the investigator and determined to notbe pathologic, for example a biopsy may be required;

24. 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;

25. 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;

26. Has chronic or acute renal and/or hepatic impairment and/or failure or prior historyof 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, socialor medical problem that may interfere with the assessment of the safety oreffectiveness of the device;

29. Current or recent history of chemical/alcohol abuse or dependency using standardmedical definition of DSM-5 code;

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

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 thatcould impact the validity of results;

33. 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.