Product Description
The Unity™ Lumbosacral Fixation System offers two unique plates with low-profile design that can be used independently or jointly. The system maximizes anterior column stabilization while minimzing the challenges of an anterior approach to lumbosacral fixation. Finely tuned and easy to handle, the low-profile and rounded surfaces reduce the potential for vascular trauma. Both plates utilize intuitive instrumentation that offers tactile feedback. Strong, flexible, and secure, the Unity Lumbosacral Fixation System's multi-faceted plate design facilitates extraordinary stability with a claw-like grip.
 
The Unity 51 Plate supports rigid single-level L5 - S1 fixation with a robust anatomically compatible design. Easily maneuverable instrumentation and friction belts reduce slippage and provide optimal control during implantation. The plate features a caudal lip that "hugs" the sacrum for easier alignment and 6.0mm and 7.0mm diameter angled screws maximize purchase. The key/keyhole feature prevents locking plate misalignment and the "double-lock" top-locking plate reduces screw back-out. Two lengths of various instrumentation address different anatomical sizes.
 
The Unity LX Plate is designed for use at the lumbar levels above L5 - S1. Available in six heights, the Unity LX Plate offers a low profile design which may reduce the risk of vascular trauma. The easy-to-read directional arrows on the plate surface ensure proper construct set-up. Based on patient need and surgeon preference, the plate can be placed anteriorly or anterolaterally. Specially designed screw orientation mitigates the risk of neuro-foramina encroachment.

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Indication
The Blackstone Unity 51 Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Blackstone Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
  • Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
  • Pseudoarthrosis
  • Spondylolysis
  • Spondylolisthesis
  • Fracture
  • Neoplastic disease
  • Unsuccessful previous fusion surgery
  • Lordotic deformities of the spine
  • Idiopathic thoracolumbar or lumbar scoliosis
  • Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele
  • Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

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Physician Benefits
Unity 51:
  • Bone screws with variable angle insertion maximize purchase
  • Key/keyhole feature prevents locking plate misalignment
  • Plate lordosis matches curve of bony endplates
  • Caudal lip hugs sacrum to simplify alignment
Unity LX:
  • Smooth surface and low profile design reduces potential vascular trauma
  • Easy-to-ready directional arrows ensure proper implant alignment
  • Optional anterior or anterolateral placement for intraoperative flexibility
  • Lateral-to-medial screw orientation reduces risk of foraminal encroachment

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Contraindications
The Blackstone Unity Lumbosacral Fixation System is contraindicated in patients with a systemic infection, with a local inflammation at the bone site, or with rapidly progressive joint disease or bone absorption syndromes such as Paget's disease, osteopenia, osteoporosis, or osteomyelitis. Do not use this system in patients with known or suspected metal allergies. Use of the system is also contraindicated in patients with any other medical, surgical or psychological condition that would preclude potential benefits of interal fixation surgery such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other disease, elevation of white blood cells or a marked shift in white blood cell differential count.

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