MOTUS Total Joint Replacement Investigational Device Exemption Study

This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite endpoints.

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 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 (\10 degrees) at the index level; 5. Congenital bony and/or spinal cord abnormalities at the level to be treated such as conjoined nerve roots that would otherwise prevent placement of the device without generating nerve damage or skeletal malformations such as kyphotic vertebra that may be better suited for a different course of treatment (e.g. spinal fusion); 6. Subcaudal defect, disrupting the integrity of the pedicle that presents undue risk of device subsidence or migration due to compromised bone quality/density; 7. Clinically compromised vertebral bodies at the index 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 (greater than or equal to 15 degrees) 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 diagnosed by surgeon using a comprehensive assessment of all available information including the following: * DEXA bone density measured T-score ≤ -1: * Females age \