When used as an intervertebral body fusion device, the PILLAR PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The PILLAR PEEK Spacer System is intended for use with autograft and supplemental internal fixation. As an example, the supplemental internal fixation system that may be used is the Orthofix Spinal Fixation System (SFS).
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR PEEK Spacer System.
The PILLAR AL PEEK spacer is used singly and is implanted using an anterior approach.
When used as a partial vertebral body replacement (VBR) System, the PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLAR PEEK Spacer System is intended for use with internal fixation. As an example, the supplemental internal fixation system that may be used is the Orthofix Spinal Fixation System (SFS).
The PILLAR PEEK Spacer System, as with other orthopedic implants, is contraindicated for use in patients:
- With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
- Who have had prior fusion at the level to be treated.