Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery

The purpose of this study is to collect on-label safety and efficacy data where InQu Bone
Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior
lumbar interbody fusion (PLIF) at multiple clinical sites.

Adverse events, time to fusion and Patient Reported Outcomes(PROs) will be recorded through
12 months follow-up.

Inclusion Criteria:

- A subject may be included if s/he meets the following criteria:

1. ≥18 years of age;

2. Able to give appropriate informed consent;

3. Willing and able to meet the proposed follow-up schedule;

4. Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis
and/or degenerative disc disease;

5. Has given appropriate consent for, and undergoes, standard-of-care
transforaminal or posterior lumber interbody fusion;

6. Use of InQu Bone Graft Extender on-label.

Exclusion Criteria:

1. Any prior lumbar fusion surgery;

2. Requires fusion surgery of more than one level;

3. Requires posterolateral fusion surgery;

4. Has fusion surgery requiring titanium cages;

5. Has a systemic infection or has infection at the site of surgery;

6. Has a medical condition or requires post-operative medication that, in the opinion of
the investigator, may interfere with bony/soft tissue healing;

7. Has any physical, social, psychological or economic condition that, in the opinion of
the investigator, may preclude accurate data collection or evaluation.