The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology

Inclusion Criteria:

1. Patient is skeletally mature and has at least moderate impairment in function,
experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with
or without back pain, and has undergone at least 6 months of non-operative treatment;

2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the
coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected
level(s), where such use is not contraindicated as noted below.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at any index lumbar level;

2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current
or past trauma or tumor (e.g., compression fracture);

3. Severe facet hypertrophy that requires extensive bone removal which would cause
instability;

4. Grade II or greater spondylolisthesis;

5. Isthmic spondylolisthesis or spondylolysis (pars fracture);

6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°);

7. Osteoporosis;

8. Back or leg pain of unknown etiology;

9. Axial back pain only, with no leg, buttock, or groin pain;

10. Morbid obesity defined as a body mass index > 40;

11. Active or chronic infection - systemic or local;

12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;

13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or
bladder dysfunction;

14. Vulnerable population including pregnant women, prisoners, students and employees of
treating physicians, and others who can be subject to coercion;

15. Patient is unwilling to complete his/her surveys.