Facet Wedge Post Market Study

1. Subjects diagnosed with at least one of the following:

   • Degenerative Disc Disease (DDD);
   • Degenerative facet joint disease (isolated facet based symptomatic back pain);
   • Pseudoarthrosis post anterior instrumentation;
2. Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
3. Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Exclusion Criteria:

Preoperative exclusion criteria:

1. Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
2. Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
3. Compromised facets due to decompression techniques;
4. Spondylolisthesis;
5. Fracture or other instabilities of the posterior elements;
6. Tumor;
7. Acute or chronic systemic or localized spinal infections;
8. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
9. Subjects aged below 18 years;

10. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation;

    Intraoperative exclusion criteria:

11. Intraoperative decision to use implants other than the device under investigation.