InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and DDD

The primary objective of this prospective, post-market study is to collect data to assess
the long term outcome of a broad contact modular interbody device in the form of the
InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for
degenerative disc disease and/or scoliosis. While there is no concurrent control population,
there is ample historical control data to be used for comparison.

The study will include up to two hundred (200) patients, up to 10 centers, and provide a
prospective evaluation of the InterFuse "T" and/or InterFuse "S" Interbody Fusion System.
Primary endpoints will be assessed at twelve months post-surgery. All patients enrolled in
the study will be followed for at least 24 months.

Inclusion Criteria:

- 1. The patients has a planned fusion construct of at least five levels and will have
the InterFuse (S) or (T) planned for L5-S1 and/or L4-L5.

2. The patient has documented conservative (non-operative) treatment for at least 6
months.

3. The patient has a VAS score of ≥ 60 mm for Back and/or Leg. 4. The patient has an
ODI ≥ 40%. 5. The general condition of the patient is appropriate for surgery, as
evaluated by the Investigator.

6. The patient is willing and able to comply with study requirements. 7. The patient
has agreed to participate in the study

Exclusion Criteria:

- 1. The patient has undergone any prior spinal fusion surgery at the proposed
treatment level(s). Previous non-fusion surgery at the proposed treatment level(s) is
acceptable.

2. The patient has osteoporosis or severe osteopenia as determined by the
Investigator. A clinical SCORE calculator may be utilized for females over 40 years
of age.

3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the
affected level(s).

4. The patient has known neoplastic disease other than skin cancer. 5. The patient
has a Body Mass Index (BMI) of greater than 40; BMI = wt (kg)/ht2 (m2).

6. The patient has an active infection. 7. The patient is pregnant or is planning on
becoming pregnant in the next two years.

8. The patient is mentally ill or has a history of drug abuse or severe depression/
psychosocial issues.

9. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel
or tantalum.

10. The patient is currently enrolled in an investigational spine study. 11. The
patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.

12. The patient has symptomatic fibrous arachroiditis.