Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease

This is a prospective, multi-center, non-randomized post-market evaluation designed to
collect and evaluate data on the safety and performance of the Fortilink IBF System with
TETRAfuse 3D Technology.

There will be 3 arms in the study, one for each configuration of the Fortilink IBF system
(Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study
arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and
European Union (EU).

Inclusion Criteria:

- The subject is skeletally mature and at least 18 years of age.

- The subject has degenerative disc disease (DDD) of the cervical spine with
accompanying radicular symptom at one or two contiguous levels (Fortilink-C), or the
subject has DDD and ≤ Grade 1 spondylolisthesis of the lumbar spine at one or two
contiguous levels (Fortilink-TS and Fortilink-L).

- Subject plans to undergo one of the following procedures:

An anterior cervical interbody fusion at one to two continuous levels from C2-C3 to C7-T1
using autogenous or allogenic bone graft and supplemental fixation cleared and indicated
for use at the proposed treatment level(s) (Fortilink-C), or

An interbody fusion in the lumbar spine at one to two continuous levels from L1-L2 to L5-S1
using autogenous or allogenic bone graft and supplemental fixation cleared and indicated
for use at the proposed treatment level(s) (Fortilink-TS and Fortilink-L).

- The subject has undergone non-operative treatment of at least six weeks (Fortilink-C)
or at least six months (Fortilink-TS and Fortilink-L) prior to treatment with the IBF
system.

- The subject is willing and able to provide informed consent.

- The subject is willing and able to attend the protocol required follow-up visits and
examinations.

Exclusion Criteria:

- The subject has an active infection

- The subject has had prior fusion attempt(s) or is undergoing revision of a previously
implanted system at the involved level(s).

- The subject is a worker's compensation case, in active litigation related to the
procedure or is a prisoner or ward of the state.

- The subject meets one or more of the contraindications outlined in the IFU.

- The subject is pregnant, nursing, or is planning to become pregnant in the next year.

- The subject has documented evidence of current substance abuse.

- The subject has other concurrent medical condition that, in the opinion of the
investigator, does not make the subject a good candidate for the study.