FIBERGRAFT Aeridyan Posterolateral Fusion Study

INCLUSION CRITERIA

• Subjects who require a 1-3 level instrumented PLF fusion in the lumbar spine in conjunction with a 1 to 2 consecutive level posterior lumbar interbody fusion procedure between L1-S1.
• Skeletally mature subjects at least 18 years of age at the time of consenting.
• Willing to provide voluntary written informed consent prior to participation in the clinical study.

EXCLUSION CRITERIA

• Subjects who had previous fusion surgery at the index level(s).
• Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels
• Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
• Pregnant subjects or planning to become pregnant within the next 24 months.
• Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
• Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors.
• Subjects who have an uncontrolled systemic or metabolic disease which, in the Investigator's opinion, would compromise their health, safety, or ability to participate or follow-up in this clinical study.
• Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator.
• Subjects that have infection or osteomyelitis at the graft site. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
• Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.
• Subjects unable to comply, and/or in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study.
• Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine
• Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s).
• Body Mass Index (BMI) ≥ 45
• Unilateral posterior instrumentation
• Subject is currently involved in a workers' compensation claim.
• Subject has participated in an interventional clinical trial within the last 6 months or plans to participate in an interventional clinical trial within the next 24 months.