A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET

Key Inclusion Criteria:

1. Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy
(neural ablation) within 18 months prior to enrollment

2. Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral

3. Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is
facetogenic

4. VAS back pain of ≥ 60 mm on a 100 mm scale, and VAS back pain is greater than or equal
to the highest VAS leg pain score

5. ODI ≥ 20 points

6. At least six (6) months of non-operative conservative management (Analgesic therapy
for a minimum of 2 weeks and a minimum of 4 weeks of NSAID therapy; Supervised
exercise and/or physical therapy program-minimum of 12 sessions)

7. At least 22 years of age and skeletally mature

Key Exclusion Criteria:

1. Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint
pain are excluded)

2. Osteoporosis or severe osteopenia

3. Lumbar fusion

4. Symptomatic spinal stenosis requiring surgical intervention

5. Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or
placement of a posterior spinous process device

6. Disc herniation requiring surgical intervention

7. The subject has a Body Mass Index (BMI) of greater than 35

8. Planned elective surgery within 12 months