Product Description
For stand-alone ALIF with four screws and partial VBR procedures the PILLAR™ SA PEEK Spacer System provides multiple sizes and lordotic angles with an ovoid shape implant to match patient anatomy.  The wide central opening holds optimal graft material while the surface teeth are designed for anti-migration.  X-ray markers provide crystal clear radiographic identification.  Varieties of flexible instrumentation assist surgeons with accessing difficult to reach anatomy.

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Indication

When used as an Intervertebral Body Fusion System:

The PILLAR SA 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 SA PEEK Spacer System is intended for use with autograft.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device.  If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability.  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 Spacer System.

When used as a Partial Vertebral Body Replacement (VBR) System:

The PILLAR SA 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 SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR SA 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 PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device.   If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability.  As an example, the supplemental internal fixation system that may be used is the Orthofix Spinal Fixation System (SFS).

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Physician Benefits
  • 4 Bone Screw design enhances implant stability
  • Medially oriented Bone Screws for optimal bone purchase
  • Wide central opening to hold optimal graft material
  • Ovoid shape parallels the apophyseal ring of the vertebral body
  • Multiple sizes match variable patient anatomies
  • Cover Plate stops the possibility of screw back-out and has a nearly zero profile
  • Multiple choices of flexible instrumentation to access difficult to reach anatomies

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Patient Benefits
The patient benefits from not requiring supplemental internal fixation such as posterior fixation or an anterior plate.
  • Cost saving for the patient
  • Cost saving for the hospital
  • Increased OR efficiencies

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